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Sigma Diagnostics, Inc.

164 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
TRIGLYCERIDE (GPO) TRINDER REAGENT (K894063)Sigma Diagnostics, Inc.1989-09-07
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE (K884184)Sigma Diagnostics, Inc.1989-03-28
WRIGHT-GLEMSA STAIN (K890673)Sigma Diagnostics, Inc.1989-02-24
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (K890674)Sigma Diagnostics, Inc.1989-02-24
HDL CHOLESTEROL REAGENT (PTA/MGCL2) (K890023)Sigma Diagnostics, Inc.1989-02-17
ACID FAST BACILLI HISTOLOGY CONTROL SLIDES (K881106)Sigma Diagnostics, Inc.1988-04-21
SPIROCHETES HISTOLOGY CONTROL SLIDES (K881109)Sigma Diagnostics, Inc.1988-04-21
FUNGI HISTOLOGY CONTROL SLIDES (K881112)Sigma Diagnostics, Inc.1988-04-21
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 (K880038)Sigma Diagnostics, Inc.1988-04-21
PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES (K881108)Sigma Diagnostics, Inc.1988-04-12
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES (K881110)Sigma Diagnostics, Inc.1988-04-12
INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES (K881107)Sigma Diagnostics, Inc.1988-03-30
INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL (K881111)Sigma Diagnostics, Inc.1988-03-30
CO2 REAGENT (K880268)Sigma Diagnostics, Inc.1988-03-15
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665 (K880039)Sigma Diagnostics, Inc.1988-02-24
RETICULOCYTE STAIN (K875310)Sigma Diagnostics, Inc.1988-02-09
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) (K874115)Sigma Diagnostics, Inc.1987-11-04
BILE ACIDS CONTROLS (K873342)Sigma Diagnostics, Inc.1987-10-20
CREATININE REAGENT (K873365)Sigma Diagnostics, Inc.1987-10-02
BILE ACIDS REAGENT (K872296)Sigma Diagnostics, Inc.1987-08-26
BILE ACIDS CALIBRATOR (K872451)Sigma Diagnostics, Inc.1987-08-21
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT (K872197)Sigma Diagnostics, Inc.1987-08-13
CHOLESTEROL REAGENT (K872295)Sigma Diagnostics, Inc.1987-07-16
DIGOXIN FPIA CONTROLS (K872347)Sigma Diagnostics, Inc.1987-07-07
PHENYTOIN FPIA CONTROLS (K871567)Sigma Diagnostics, Inc.1987-07-01
SIGMA'S CALCIUM PROCEDURE NO. 587 (K871152)Sigma Diagnostics, Inc.1987-06-12
PHENYTOIN FPIA CALIBRATORS (K871423)Sigma Diagnostics, Inc.1987-06-11
THEOPHYLLINE FPIA CALIBRATORS (K871394)Sigma Diagnostics, Inc.1987-06-01
METHYL GREEN SOLUTION (K871544)Sigma Diagnostics, Inc.1987-04-29
NEW FUCHSIN SOLUTION (K871545)Sigma Diagnostics, Inc.1987-04-29
DIGOXIN FPIA REAGENT SET (K870951)Sigma Diagnostics, Inc.1987-04-01
PHENYTOIN FPIA REAGENT SET (K870953)Sigma Diagnostics, Inc.1987-03-31
THEOPHYLLINE FPIA REAGENT SET (K870952)Sigma Diagnostics, Inc.1987-03-31
TRIGLYCERIDE (GPO-TRINDER) REAGENT (K870012)Sigma Diagnostics, Inc.1987-02-20
CHLORIDE REAGENT (K864713)Sigma Diagnostics, Inc.1986-12-31
TISSUE GRAM STAIN (K864531)Sigma Diagnostics, Inc.1986-12-22
MULTI-ANALYTE LIN-TROL (K863751)Sigma Diagnostics, Inc.1986-11-24
RAPID ACID FAST STAIN (K864033)Sigma Diagnostics, Inc.1986-11-13
ELASTIC STAIN (K864074)Sigma Diagnostics, Inc.1986-10-29
ACID PHOSPHATASE (ACP) REAGENT (K863851)Sigma Diagnostics, Inc.1986-10-16
ALBUMIN (BCP) (K863226)Sigma Diagnostics, Inc.1986-09-17
CHOLINESTERASE (BTC) REAGENT (K863203)Sigma Diagnostics, Inc.1986-09-17
CHOLINESTERASE (PTC) REAGENT (K863202)Sigma Diagnostics, Inc.1986-09-16
ALP (OPT) REAGENT (K862905)Sigma Diagnostics, Inc.1986-08-29
BUN (RATE) REAGENT (K863196)Sigma Diagnostics, Inc.1986-08-26
CHOLESTEROL CALIBRATORS (K861314)Sigma Diagnostics, Inc.1986-07-01
ALBUMIN (BCG) REAGENT (K861467)Sigma Diagnostics, Inc.1986-05-23
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM (K860138)Sigma Diagnostics, Inc.1986-03-28
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 (K860453)Sigma Diagnostics, Inc.1986-02-19
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV (K854245)Sigma Diagnostics, Inc.1986-01-22
CK(OPTIMIZED) REAGENT (K854501)Sigma Diagnostics, Inc.1985-12-04
ALT(OPTIMIZED) REAGENT (K854502)Sigma Diagnostics, Inc.1985-11-25
AST(OPTIMIZED) REAGENT (K854503)Sigma Diagnostics, Inc.1985-11-25
SIGMA 610 FOR PROTEIN IN URINE & CSF (K853681)Sigma Diagnostics, Inc.1985-10-28
GRAM STAIN KIT (K853896)Sigma Diagnostics, Inc.1985-10-22
URIC ACID REAGENT (K853357)Sigma Diagnostics, Inc.1985-08-19
BUN(ENDPOINT) REAGENT (K852131)Sigma Diagnostics, Inc.1985-06-10
GLUCOSE(TRINDER) REAGENT (K852130)Sigma Diagnostics, Inc.1985-06-10
BUN (RATE) REAGENT (K850923)Sigma Diagnostics, Inc.1985-03-20
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT (K850319)Sigma Diagnostics, Inc.1985-02-12
TRIGLYCERIDE CALIBRATOR (K844468)Sigma Diagnostics, Inc.1984-12-11
TRIGLYCERIDE REAGENT (K844032)Sigma Diagnostics, Inc.1984-11-09
SIGMS PROCED. 228 UV LACTATE DEHYDRO (K841917)Sigma Diagnostics, Inc.1984-06-14
SIGMA PROCED. 245 ALKALINE PHOSPHATASE (K841918)Sigma Diagnostics, Inc.1984-06-14
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