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General Diagnostics

Mchenry, IL, US

General Diagnostics appears in FDA device records in Mchenry, IL. FDA records list 39 510(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
39
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 39 510(k) clearances for General Diagnostics between 1976 and 1988. The busiest year on record is 1979, with 7. The most recent is 1988, with 1.

Clearances by year, as a table
510(k) clearance decisions for General Diagnostics, by decision year
YearClearances
19761
19772
19782
19797
19805
19814
19825
19836
19842
19874
19881
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K882663BARBITURATE ENZYME IMMUNOASSAY KITDISSubstantially Equivalent
K872882CANNABINOID ENZYME IMMUNOASSAY KITLDJSubstantially Equivalent
K871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITDIOSubstantially Equivalent
K864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEDISSubstantially Equivalent
K863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITJXMSubstantially Equivalent
K842307GENERAL DIAG. CEFONICID 30MCG ANTIMICJTNSubstantially Equivalent
K841465GENERAL DIAGNOSTICS PLATELET ANTIBODYLLGSubstantially Equivalent
K833709CEFTIZOXIME 30 MCG ANTIMICROBIAL DISKJTNSubstantially Equivalent
K832653CEFUROXIME 30MCG. SUSCEP DISKJTNSubstantially Equivalent
K831179CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEPJTNSubstantially Equivalent
K830731NETILMICIN 30 MCG ANTIMICROBIAL DISKJTNSubstantially Equivalent
K823453VON WILLEBRAND FACTOR ASSAYGGPSubstantially Equivalent
K823794CONTROL TM 8GLQSubstantially Equivalent
K822809AZLOCILLIN 75 MCG SUSCEPTIBILITY DISCJTNSubstantially Equivalent
K821229CEFOPERAZONE 75MCG. ANTIMICROBIAL DISKJTNSubstantially Equivalent
K820468PROFILE GENERAL SET ASSAYED SERUM CONTRDIFSubstantially Equivalent
K820019PIPERACILLIN 100MCG. ANTIMICROBIALJTNSubstantially Equivalent
K813564COAG-A-MATE X2GKPSubstantially Equivalent
K812994MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSKJTNSubstantially Equivalent
K812993MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISKJTNSubstantially Equivalent
K812916MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. DJTNSubstantially Equivalent
K812783TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISKJTNSubstantially Equivalent
K803039PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.DIFSubstantially Equivalent
K803036PROFILE CARDIAC SET ASSAYED SERUM CONTR.DIFSubstantially Equivalent
K802117FIBRI QUIKGJASubstantially Equivalent
K800925VERIFY S PROD. #34141GGWSubstantially Equivalent
K800926THROMBOQUIK THROMBIN REAGENT PROD. #3551GJASubstantially Equivalent
K792480CHEM-STRATE TRIGLYCERIDECDTSubstantially Equivalent
K792479CHEM-STRATE AMYLASECIJSubstantially Equivalent
K792478CHEM-STRATE CHOLESTEROLCHHSubstantially Equivalent
K792477CHEM-STRATE CK-NACCGSSubstantially Equivalent
K790372H-D-ELLBRSubstantially Equivalent
K790323COAG-A-MATE 2001JPASubstantially Equivalent
K781781HEPARSORBGJASubstantially Equivalent
K781814SULFATE, FIBRIQUIK PROTAMINEJBNSubstantially Equivalent
K780285SOLUBLE COLLAGENJOZSubstantially Equivalent
K772106PH CALIBRATION BUFFERSJITSubstantially Equivalent
K761250SIMPLATEJCASubstantially Equivalent
K760790MICRO-IDJSSSubstantially 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

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Claiming lets General Diagnostics edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

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