Sigma Diagnostics, Inc.
Sigma Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 1984, most recent 2002.
Clearances by Sigma Diagnostics, Inc. — page 2
101–164 of 164- K894063 — TRIGLYCERIDE (GPO) TRINDER REAGENT
- K884184 — SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
- K890673 — WRIGHT-GLEMSA STAIN
- K890674 — ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
- K890023 — HDL CHOLESTEROL REAGENT (PTA/MGCL2)
- K880038 — FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
- K881106 — ACID FAST BACILLI HISTOLOGY CONTROL SLIDES
- K881109 — SPIROCHETES HISTOLOGY CONTROL SLIDES
- K881112 — FUNGI HISTOLOGY CONTROL SLIDES
- K881108 — PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES
- K881110 — LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
- K881107 — INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES
- K881111 — INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL
- K880268 — CO2 REAGENT
- K880039 — AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
- K875310 — RETICULOCYTE STAIN
- K874115 — NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
- K873342 — BILE ACIDS CONTROLS
- K873365 — CREATININE REAGENT
- K872296 — BILE ACIDS REAGENT
- K872451 — BILE ACIDS CALIBRATOR
- K872197 — PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT
- K872295 — CHOLESTEROL REAGENT
- K872347 — DIGOXIN FPIA CONTROLS
- K871567 — PHENYTOIN FPIA CONTROLS
- K871152 — SIGMA'S CALCIUM PROCEDURE NO. 587
- K871423 — PHENYTOIN FPIA CALIBRATORS
- K871394 — THEOPHYLLINE FPIA CALIBRATORS
- K871544 — METHYL GREEN SOLUTION
- K871545 — NEW FUCHSIN SOLUTION
- K870951 — DIGOXIN FPIA REAGENT SET
- K870952 — THEOPHYLLINE FPIA REAGENT SET
- K870953 — PHENYTOIN FPIA REAGENT SET
- K870012 — TRIGLYCERIDE (GPO-TRINDER) REAGENT
- K864713 — CHLORIDE REAGENT
- K864531 — TISSUE GRAM STAIN
- K863751 — MULTI-ANALYTE LIN-TROL
- K864033 — RAPID ACID FAST STAIN
- K864074 — ELASTIC STAIN
- K863851 — ACID PHOSPHATASE (ACP) REAGENT
- K863203 — CHOLINESTERASE (BTC) REAGENT
- K863226 — ALBUMIN (BCP)
- K863202 — CHOLINESTERASE (PTC) REAGENT
- K862905 — ALP (OPT) REAGENT
- K863196 — BUN (RATE) REAGENT
- K861314 — CHOLESTEROL CALIBRATORS
- K861467 — ALBUMIN (BCG) REAGENT
- K860138 — NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
- K860453 — ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
- K854245 — SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
- K854501 — CK(OPTIMIZED) REAGENT
- K854502 — ALT(OPTIMIZED) REAGENT
- K854503 — AST(OPTIMIZED) REAGENT
- K853681 — SIGMA 610 FOR PROTEIN IN URINE & CSF
- K853896 — GRAM STAIN KIT
- K853357 — URIC ACID REAGENT
- K852130 — GLUCOSE(TRINDER) REAGENT
- K852131 — BUN(ENDPOINT) REAGENT
- K850923 — BUN (RATE) REAGENT
- K850319 — Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT
- K844468 — TRIGLYCERIDE CALIBRATOR
- K844032 — TRIGLYCERIDE REAGENT
- K841917 — SIGMS PROCED. 228 UV LACTATE DEHYDRO
- K841918 — SIGMA PROCED. 245 ALKALINE PHOSPHATASE
Data sourced from openFDA. This site is unofficial and independent of the FDA.