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

Mchenry, IL, US

Calbiochem-Behring Corp. appears in FDA device records in Mchenry, IL. FDA records list 41 510(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
41
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 41 510(k) clearances for Calbiochem-Behring Corp. between 1978 and 1983. The busiest year on record is 1980, with 14. The most recent is 1983, with 3.

Clearances by year, as a table
510(k) clearance decisions for Calbiochem-Behring Corp., by decision year
YearClearances
19784
197912
198014
19815
19823
19833
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K831811REVOLUTION RADIAL IMMUNODIFFUSION PLATEJZQSubstantially Equivalent
K831036ENA TEST KIT SM & RNP AUTO ANTIBODYLLLSubstantially Equivalent
K830214AFT SYSTEM IIIDHNSubstantially Equivalent
K820812CREATINE KINASE-MB KITJHYSubstantially Equivalent
K813493ENZYGNOST TM RUBELLA IGMLFXSubstantially Equivalent
K820088AFT SYSTEM PROFICIENCY TESTING PROGRAMDBLSubstantially Equivalent
K812458PADACJTOSubstantially Equivalent
K810718C-PEPTICE REAGENTSJKDSubstantially Equivalent
K810669PANTRAK E.K.CIWSubstantially Equivalent
K810404RHEUMATOID FACTORS REFERENCE SERUMDHRSubstantially Equivalent
K810309RUBELLA ANTIBODIES TEST REAGENTSGOLSubstantially Equivalent
K802102RUBELLA ELISA REAGENTS RUBELLA IGG ANTIGOLSubstantially Equivalent
K802153CBC PAP TEST KITJFHSubstantially Equivalent
K801198FOLATE RADIOASSAY KITCGNSubstantially Equivalent
K801123TRIIODOTHYRONINE RADIOIMMUN. SYSTEMCDPSubstantially Equivalent
K801105THYROXINE RADIOIMMUNOASSAY KITCDXSubstantially Equivalent
K800995IMMUNOGLOBULIN E TEST KITDGOSubstantially Equivalent
K800821AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODYDBMSubstantially Equivalent
K800820AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODYDBESubstantially Equivalent
K800642RAPI/TEX ASO STANDARD SERUMGTQSubstantially Equivalent
K800212COMPLEMENT C3 REAGENT SYSTEMCZWSubstantially Equivalent
K800211IMMUNOGLOBULIN A REAGENT SYSTEMCZPSubstantially Equivalent
K792460CALBIOCHEM-BEHRING RIA-COUNTCDDSubstantially Equivalent
K800167IMMUNOGLOBULIN M REAGENT SYSTEMDFTSubstantially Equivalent
K800119IMMUNOGLOBULIN G REAGENT SYSTEMDEWSubstantially Equivalent
K791358FIBRO-TEC TEST KITGHHSubstantially Equivalent
K791118HLA CONTROL SERALGOSubstantially Equivalent
K791117RABBIT COMPLEMENTKTQSubstantially Equivalent
K790997ANTI-DNASE B REAGENT SYSTEMGTRSubstantially Equivalent
K790911RIA OF PROGESTERONEJLSSubstantially Equivalent
K790773ENZYMATIC TRIGLYCERIDES-S.V.R.CDTSubstantially Equivalent
K790460TXOCELL-IHA REAGENT SYSTEMGMMSubstantially Equivalent
K790556CHOLESTEROL REAGENT, AUTOMATED ENZYMATICCHHSubstantially Equivalent
K790280AUTOANTIBODY REAGENTS, AFT SYSTEM IIDHNSubstantially Equivalent
K790330CALBIOCHEM-BEHRING LASER IMMUNOGLOBULINJJYSubstantially Equivalent
K790012RHEUMOGEN TEST SYSTEMDHRSubstantially Equivalent
K781996ACID REAGENT, URIC SINGLE VIALCDOSubstantially Equivalent
K781527RIA SYSTEM FOR HUMAN FE-RITINJMGSubstantially Equivalent
K780870RIA SYSTEM FOR HUMAN F-S HORMONECGJSubstantially Equivalent
K780367RIA SYS. FOR HUMAN LUTEINIZING HORMONECEPSubstantially Equivalent
K780347RIA SYS. FOR HUMAN GROWTH HORMONECFLSubstantially 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