510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sigma Chemical Co.

Mchenry, IL, US

Sigma Chemical Co. appears in FDA device records in Mchenry, IL. FDA records list 231 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
231
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 231

FDA records hold 231 510(k) clearances for Sigma Chemical Co. between 1976 and 1994. The busiest year on record is 1987, with 37. The most recent is 1994, with 3.

Clearances by year, as a table
510(k) clearance decisions for Sigma Chemical Co., by decision year
YearClearances
197614
197710
19784
19797
19804
19814
19826
198335
198431
198522
19864
198737
19888
19898
199021
19914
19939
19943
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K933694SIGMA GLUCOSE REAGENTCGASubstantially Equivalent
K933678SIGMA CALCIUM REAGENTCJYSubstantially Equivalent
K933696SIGMA ELECTROLYTE REFERENCE REAGENTJFLSubstantially Equivalent
K933691SIGMA CO2 ALKALINE BUFFER REAGENTJFLSubstantially Equivalent
K933679SIGMA BUN REAGENTLFPSubstantially Equivalent
K933703SIGMA WASH CONCENTRATE SOLUTIONJJESubstantially Equivalent
K933692SIGMA CO2 ACID REAGENTJFLSubstantially Equivalent
K933695SIGMA ELECTROLYTE BUFFERJFLSubstantially Equivalent
K933697SIGMA CRE REAGENTCGXSubstantially Equivalent
K933693SIGMA CX-3 CALIBRATION STANDARD LEVEL 2JIXSubstantially Equivalent
K933702SIGMA CX-3 CALIBRATION STANDARD LEVEL 1JIXSubstantially Equivalent
K930050SIA THYROID STIMULATING HORMONE ELISA KITJLWSubstantially Equivalent
K901189MONOCLONAL ANTIBODY ANTI-CD3GKZSubstantially Equivalent
K901188MONOCLONAL ANTIBODY ANTI-CD5GKZSubstantially Equivalent
K901187MONOCLONAL ANTIBODY ANTI-CD2GKZSubstantially Equivalent
K901186MONOCLONAL ANTIBODY ANTI-CD19GKZSubstantially Equivalent
K904022NITRO BLUE TETRAZOLIUM REDUCTIONGHDSubstantially Equivalent
K903995NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KITGHDSubstantially Equivalent
K904341APTT REAGENTGFOSubstantially Equivalent
K902098CHOLESTEROL (RATE) REAGENTCHHSubstantially Equivalent
K902363COAGULATION CONTROL, LEVEL IIIGGNSubstantially Equivalent
K902362COAGULATION CONTROL, LEVEL IIGGNSubstantially Equivalent
K902361COAGULATION CONTROL, LEVEL IGGNSubstantially Equivalent
K902294ACCUSCAN MICROBEAD STANDARDSJIWSubstantially Equivalent
K902096THROMBOPLASTIN WITH CALCIUMGJSSubstantially Equivalent
K901675APOLIPOPROTEIN A-I (APO A-I)DELSubstantially Equivalent
K900906FACTOR II DEFICIENT PLASMAGJTSubstantially Equivalent
K900412FACTOR XII DEFICIENT PLASMAGJTSubstantially Equivalent
K900411FACTOR XI DEFICIENT PLASMAGJTSubstantially Equivalent
K900410FACTOR X DEFICIENT PLASMAGJTSubstantially Equivalent
K900409FACTOR IX DEFICIENT PLASMAGJTSubstantially Equivalent
K900408FACTOR VIII DEFICIENT PLASMAGJTSubstantially Equivalent
K900407FACTOR VII DEFICIENT PLASMAGJTSubstantially Equivalent
K900406FACTOR V DEFICIENT PLASMAGJTSubstantially Equivalent
K900124APOLIPOPROTEIN B (APO B)DELSubstantially Equivalent
K896258CO2 REAGENT (340 NM)KHSSubstantially Equivalent
K896650AMYLASE REAGENTJFJSubstantially Equivalent
K896545ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)GFOSubstantially Equivalent
K896092ALKALINE PHOSPHATASE, LEUKOCYTE, KITGHDSubstantially Equivalent
K894467THROMBIN TIME REAGENTGJASubstantially Equivalent
K893560ALT REAGENT (PROCEDURE NUMBER 159)CKASubstantially Equivalent
K893416URIC ACID REAGENT (PROCEDURE NUMBER 686)KNKSubstantially Equivalent
K892844AST REAGENT (PROCEDURE NUMBER 158)CITSubstantially Equivalent
K885272CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDEDIHSubstantially Equivalent
K890278TOTAL PROTEIN REAGENTCEKSubstantially Equivalent
K884574DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785KITSubstantially Equivalent
K884573HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891KITSubstantially Equivalent
K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382KITSubstantially Equivalent
K883972MAGNESIUM REAGENT (MAGON SULFONATE)JGJSubstantially Equivalent
K883525OXALATE REAGENTLPWSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain