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

Mchenry, IL, US

Reagents Applications, Inc. appears in FDA device records in Mchenry, IL. FDA records list 63 510(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
63
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 63

FDA records hold 63 510(k) clearances for Reagents Applications, Inc. between 1980 and 1998. The busiest year on record is 1990, with 9. The most recent is 1998, with 1.

Clearances by year, as a table
510(k) clearance decisions for Reagents Applications, Inc., by decision year
YearClearances
19804
19814
19825
19835
19846
19853
19864
19876
19886
19893
19909
19915
19921
19971
19981
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K982056RAICHEM CO2 REAGENTKHSSubstantially Equivalent
K972853CHOLESTEROL RAPID LIQUID REAGENTCHHSubstantially Equivalent
K922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIJJXSubstantially Equivalent
K915191RAI-TROL ELEVATED LIPIDS CONTROLJJYSubstantially Equivalent
K913398RAICHEM(TM) CREATINE KINASE-MB REAGENTCGSSubstantially Equivalent
K911900RAICHEM SPIA C3 REAGENTCZWSubstantially Equivalent
K911899RAICHEM SPIA C4 REAGENTDBISubstantially Equivalent
K911898RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENTDADSubstantially Equivalent
K905085RAICHEM GGT REAGENTJQBSubstantially Equivalent
K905084RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UVCGSSubstantially Equivalent
K904175RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENTLKLSubstantially Equivalent
K903123RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENTJIQSubstantially Equivalent
K902593RAICHEM(TM) SPIA(TM) CRP REAGENTDCNSubstantially Equivalent
K900875RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENTDDGSubstantially Equivalent
K896845RAICHEM(TM) UREA NITROGEN (COLOR) REAGENTCDLSubstantially Equivalent
K896922RAICHEM TM HEMOGLOBIN REAGENTGKKSubstantially Equivalent
K896921RAICHEM TM HEMOGLOBIN CALIBRATORKRZSubstantially Equivalent
K894418RAICHEM(TM) SPIA(TM) IGA REAGENTSCZPSubstantially Equivalent
K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSDFTSubstantially Equivalent
K894416RAICHEM(TM) SPIA(TM) IGG REAGENTSKTOSubstantially Equivalent
K883389RAICHEM(TM) BILIRUBIN CONJUGATE STANDARDJIWSubstantially Equivalent
K882726RAICHEM(TM) BILIRUBIN STANDARDJISSubstantially Equivalent
K880576RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)CJYSubstantially Equivalent
K880880RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATICJGJSubstantially Equivalent
K874822RAICHEM(TM) MAGNESIUM REAGENTJGJSubstantially Equivalent
K874382RAICHEM(TM) ALCOHOL REAGENTDMLSubstantially Equivalent
K872080RAICHEM(TM) SPIA(TM) APO B REAGENTSDFCSubstantially Equivalent
K872079RAICHEM(TM) SPIA(TM) APO A-1 REAGENTSMSJSubstantially Equivalent
K870776RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINTCEOSubstantially Equivalent
K864992RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)JFYSubstantially Equivalent
K864819RAICHEM (TM)SERUM IRON AND TIBC REAGENTSJIYSubstantially Equivalent
K864706RAICHEM(TM) AMMONIA REAGENTJIFSubstantially Equivalent
K863620RAICHEM(TM) CHLORIDE REAGENTCHJSubstantially Equivalent
K862168RAICHEM CHOLINESTERASE REAGENTDIHSubstantially Equivalent
K861718AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109JFJSubstantially Equivalent
K861269RAICHEM AMYLASE REAGENTJFJSubstantially Equivalent
K854544RAICHEM CO2 REAGENTKHSSubstantially Equivalent
K854540RAICHEM/K.EJJQSubstantially Equivalent
K844316RAICHEM PHOSPHORUS REAGENTCEOSubstantially Equivalent
K843774RAICHEM X-HBDH REAGENTJMKSubstantially Equivalent
K843353RAICHEM CALCIUM REAGENTCICSubstantially Equivalent
K842029TRIGLYCERIDES-GPO REAGENTCDTSubstantially Equivalent
K841892RAICHEM BILIRUBIN REAGENT TOTAL/DIRECTCIGSubstantially Equivalent
K841466TOTAL PROTEIN REAGENT BIURETCEKSubstantially Equivalent
K840872RAICHEM CREATININE REAGENTCGXSubstantially Equivalent
K832463RAICHEM ALKALINE PHOSPHATASE REAGENTCJESubstantially Equivalent
K831834RAICHEM ACID PHASPHATASE REAGENTCKBSubstantially Equivalent
K831585ALBUMIN REAGENT (BCGCIXSubstantially Equivalent
K831419RAICHEM LDH-P REAGENT W/SEPARATE START-CFJSubstantially Equivalent
K830207RAICHEM HDL-CHOLESTEROL REAGENTLBRSubstantially 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