Syva Co.
FDA 510(k) medical device clearances.
Top product codes for Syva Co.
Recent clearances by Syva Co.
1–100 of 448- K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
- K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
- K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
- K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
- K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
- K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
- K993026 — ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
- K993028 — ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90
- K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89
- K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
- K993982 — SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
- K993983 — SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
- K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
- K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
- K993987 — SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
- K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
- K994005 — SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
- K993984 — SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
- K993755 — EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
- K984232 — MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
- K951755 — EMIT 2000 DIGOXIN ASSAY
- K935192 — EMIT IIC CALIBRATORS
- K935116 — EMIT IIC BARBITURATE ASSAY
- K935191 — EMIT IIC PHENCYCLIDINE ASSAY
- K935323 — EMIT IIC COCAINE METABOLITE ASSAY
- K935352 — EMIT(R) IIC AMPHETAMINE ASSAY
- K940158 — EMIT IIC CANNABINOID ASSAY
- K943500 — EMIT 2000 DIGOXIN ASSAY
- K942619 — EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
- K941235 — VISTA B12 ASSAY
- K934135 — EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
- K935117 — EMIT(R) IIC OPIATE ASSAY
- K935230 — EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
- K934121 — VISTA FOLATE ASSAY
- K932716 — EMIT(R) THC 50/100 NG ASSAY
- K926090 — SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
- K931123 — DIGOXIN TEST SYSTEM, KXT TX
- K931576 — VISTA FERRITIN ASSAY
- K931535 — EMIT(R) D.A.U. BARBITURATE ASSAY
- K926422 — VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
- K926394 — VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
- K931536 — EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
- K926386 — VISTA PROLACTIN ASSAY
- K926342 — VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
- K926067 — EMIT(R) II BENZODIAZEPINE ASSAY
- K926068 — EMIT(R) II BARBITURATE ASSAY
- K923572 — VISTA FREE THYROXINE ASSAY
- K923873 — SYVA EMIT II PROPOXYPHENE ASSAY
- K923571 — VISTA TRIIODOTHYRONINE ASSAY
- K923676 — VISTA THYROXINE UPTAKE ASSAY
- K921747 — MICRO TRAK XL SYSTEM
- K920503 — SYVA MICROTRAK CHLAMYDIA EIA
- K921462 — MICROTRAK(R) II CHLAMYDIA EIA ASSAY
- K922433 — VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
- K922913 — EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
- K922914 — EMIT 2000 PROCAINAMIDE CALIBRATORS
- K922915 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
- K922138 — VISTA ULTRASENSITIVE HTSH ASSAY
- K922139 — VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
- K921013 — SYVA EMIT II METHAQUALONE ASSAY
- K920751 — SYVA EMIT II METHADONE ASSAY
- K920507 — EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
- K915501 — EMIT D.A.U BENZODIAZEPINE ASSAY
- K915728 — EMIT D.A.U. PHENCYCLIDINE ASSAY
- K914973 — SYVA EMIT D.A.U. COCAINE METABOLITE
- K915003 — EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
- K913840 — MICROTAK PLUS
- K913123 — EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
- K913410 — EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS
- K913190 — EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
- K913429 — EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
- K913066 — EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
- K912959 — MICROTRAK MANAGER
- K912729 — EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
- K912055 — SYVA EDMS
- K910527 — EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE
- K905179 — SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
- K910376 — EMIT II BENZODIAZEPINE ASSAY
- K904990 — EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
- K904568 — EMIT(R) II CANNABINOID 100 NG ASSAY
- K904569 — EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
- K904570 — EMIT(R) II CANNABINOID 20 NG ASSAY
- K904571 — EMIT(R) II CANNABINOID 50 NG ASSAY
- K904765 — EMIT (R) II PHENCYCLIDINE ASSAY
- K904764 — EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)
- K903357 — SYVA(R) ETS(R) PLUS SYSTEM
- K903758 — SYVA MICROTRAK EIA ACCESSORY REAGENTS
- K903152 — EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
- K903228 — EMIT ETS PLUS ETHYL ALCOHOL ASSAY
- K903153 — EMIT ETHYL ALCOHOL ASSAY
- K902577 — EMIT(R) II OPIATE ASSAY
- K902579 — EMIT(R) II COCAINE METABOLITE ASSAY
- K902581 — EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
- K902580 — EMIT(R) II BARBITURATE ASSAY
- K902578 — EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2
- K901573 — EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B
- K900995 — EMIT D.A.U. AMPHETAMINE CLASS ASSAY
- K897114 — EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
- K896070 — PFEIFFER METERED DOSAGE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.