Helena Laboratories
Helena Laboratories holds FDA 510(k) medical device clearances, first cleared 1978, most recent 2013.
Clearances by Helena Laboratories — page 2
101–200 of 280- K905807 — HELENA THROMBOPLASTIN REAGENT WITH DILUENT
- K911468 — REP SPE PLUS (ACID BLUE) SYSTEM
- K905857 — HELENA THROMBOPLASTIN REAGENT, MODIFICATION
- K905673 — AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
- K904247 — FREE PROTEIN S REAGENT CAT. NO. 5363
- K905149 — TITAN GEL
- K904035 — REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
- K901414 — COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
- K902083 — CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
- K901463 — REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)
- K901805 — REP(R) IMMUNOFIX
- K901380 — CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
- K901143 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
- K896670 — TIP TOP(R) DISPENSER CAPS
- K896174 — PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
- K900422 — TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
- K900251 — REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
- K896170 — REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
- K897136 — PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
- K900017 — REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
- K900019 — ROCKET REFERENCE PLASMA, CAT NO. 5188
- K896572 — REP(TM) SPE PLUS-30 PROCEDURES
- K893038 — PROTOFLUOR Z
- K895528 — GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
- K894585 — REP TM SPE (PONCEAU S) PROCEDURES
- K894366 — REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
- K893007 — REP(TM) CK-2 STAT KIT, CAT. NO. 3074
- K892818 — REP(TM) LD-2 STAT KIT, CAT. NO. 3078
- K893224 — REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
- K893211 — REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
- K892424 — REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
- K893223 — REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181
- K892050 — HELENA THROMBOPLASTIN REAGENT
- K891683 — TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
- K891188 — TITAN GEL IFE TRIVALENT ANTISERUM
- K891299 — MID-LEVEL IGG KIT CAT. NO. 9315
- K885341 — TITAN GEL ALKALINE PHOSPHATASE (HR)
- K884315 — LABILE LYSING REAGENT
- K884111 — PUMPETTE(TM)
- K881863 — REP GLYCO SYSTEM
- K882799 — HELENA COLOCARE
- K883484 — OWREN'S VERONAL BUFFER
- K882368 — REP HDL ELECTROPHORESIS METHOD
- K881852 — REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
- K882163 — HELENA REP GEL PROCESSOR
- K881809 — REP LIPO KIT CAT. NO 3180
- K880698 — TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
- K880653 — HBF DILUENT
- K880292 — FACTOR VIII REFERENCE PLASMA
- K874142 — TITAN GEL REP LDH-30 HV
- K874145 — TITAN GEL REP LDH-6 HV
- K874143 — TITAN GEL REP LDH-12 HV
- K874144 — TITAN GEL REP CPK-6 HV
- K873384 — CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
- K874146 — TITAN GEL REP CPK-12 HV
- K874141 — TITAN GEL REP CPK/LDH ISOENZYME CONTROL
- K874139 — TITAN GEL REP CPK-30 HV
- K874140 — TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.
- K873386 — TITAN GEL LDH REP SYSTEM
- K873399 — TITAN GEL CPK REP SYSTEM
- K873547 — TITAN GEL HDL CHOLESTEROL KIT
- K873352 — RAPID ELECTROPHORESIS SYSTEM (REP)
- K871499 — PROTOFLUOR Z
- K872834 — TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
- K872377 — CHROM-TROL
- K871318 — Q.I.C. BLEEDING TIME DEVICE
- K870890 — ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
- K870958 — TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091
- K871498 — TITAN GEL IMMUNOFIX CONTROLS
- K871319 — TITAN GEL MULTI-SLOT LIPO-17 SYSTEM
- K871352 — PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
- K860645 — ELECTROPHORESIS DATA CENTER (EDC)
- K861414 — ELECTROPHORESIS WORK CENTER (EWC)
- K862701 — SURESPOT
- K860309 — HEMAFLUOR REAGENT KIT
- K861750 — CK/LD BUFFER (CAT. NO. 5808)
- K861490 — PERMACLEAR SOLUTION CAT. NO. 4950
- K852392 — EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
- K852391 — EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
- K851669 — MONITOR IV PLUS
- K843352 — COLOSCREEN SELF-TEST
- K842669 — TITAN GEL ISO DOT LDH KIT
- K842689 — GLYCO-TEK AFFINITY COLUMN
- K842755 — TITAN GEL ISO DOT CPK PROCEDURE
- K840903 — HELENA COLOSCREEN SELF-TEST
- K841020 — FIBRINOGEN ASSAY KIT
- K840848 — BIOSURE
- K840329 — RISTOCETIN COFACTOR ASSAY
- K833611 — TITAN GEL LIPOPROTEIN ELECTROPHORESIS
- K833855 — TITAN GEL SILVER STAIN SYSTEM
- K833772 — AUTO AIC ANALYZER SYSTEM
- K834456 — HELENA BIO STRIP OB
- K833639 — TITANGEL HIGH RESOLUTION CONTROL
- K834031 — FACTOR II DEFICIENT SUBSTRATE PLASMA
- K832864 — COLOSCREEN V.P.I.
- K833356 — GLYCO-JE,E CPMTRP; -NORMAL/ABNORMAL
- K832428 — PLATELET AGGREGATION REAGENT SET
- K832496 — BIO SURE STAIN
- K832087 — TITAN GEL GLYCO-HEME SYSTEM
- K831994 — BIOCHECK POSITIVE URINE CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.