Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Calbiochem-Behring Corp. — Predicate Candidate Screening

41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

31 daysmedian FDA review time

69 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days
K831811	REVOLUTION RADIAL IMMUNODIFFUSION PLATE	Calbiochem-Behring Corp.	1983-07-28	52
K831036	ENA TEST KIT SM & RNP AUTO ANTIBODY	Calbiochem-Behring Corp.	1983-04-27	27
K830214	AFT SYSTEM III	Calbiochem-Behring Corp.	1983-03-09	44
K820812	CREATINE KINASE-MB KIT	Calbiochem-Behring Corp.	1982-04-12	20
K813493	ENZYGNOST TM RUBELLA IGM	Calbiochem-Behring Corp.	1982-03-04	80
K820088	AFT SYSTEM PROFICIENCY TESTING PROGRAM	Calbiochem-Behring Corp.	1982-01-26	13
K812458	PADAC	Calbiochem-Behring Corp.	1981-09-23	23
K810718	C-PEPTICE REAGENTS	Calbiochem-Behring Corp.	1981-03-31	14
K810669	PANTRAK E.K.	Calbiochem-Behring Corp.	1981-03-31	19
K810404	RHEUMATOID FACTORS REFERENCE SERUM	Calbiochem-Behring Corp.	1981-03-11	21
K810309	RUBELLA ANTIBODIES TEST REAGENTS	Calbiochem-Behring Corp.	1981-03-11	34
K802102	RUBELLA ELISA REAGENTS RUBELLA IGG ANTI	Calbiochem-Behring Corp.	1980-12-18	106
K802153	CBC PAP TEST KIT	Calbiochem-Behring Corp.	1980-11-12	65
K801198	FOLATE RADIOASSAY KIT	Calbiochem-Behring Corp.	1980-07-21	63
K801123	TRIIODOTHYRONINE RADIOIMMUN. SYSTEM	Calbiochem-Behring Corp.	1980-06-09	28
K801105	THYROXINE RADIOIMMUNOASSAY KIT	Calbiochem-Behring Corp.	1980-06-09	31
K800995	IMMUNOGLOBULIN E TEST KIT	Calbiochem-Behring Corp.	1980-05-14	19
K800820	AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY	Calbiochem-Behring Corp.	1980-04-24	13
K800642	RAPI/TEX ASO STANDARD SERUM	Calbiochem-Behring Corp.	1980-04-24	31
K800821	AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY	Calbiochem-Behring Corp.	1980-04-24	13
K800211	IMMUNOGLOBULIN A REAGENT SYSTEM	Calbiochem-Behring Corp.	1980-02-19	18
K800212	COMPLEMENT C3 REAGENT SYSTEM	Calbiochem-Behring Corp.	1980-02-19	18
K792460	CALBIOCHEM-BEHRING RIA-COUNT	Calbiochem-Behring Corp.	1980-02-13	72
K800167	IMMUNOGLOBULIN M REAGENT SYSTEM	Calbiochem-Behring Corp.	1980-02-05	11
K800119	IMMUNOGLOBULIN G REAGENT SYSTEM	Calbiochem-Behring Corp.	1980-02-05	18
K791358	FIBRO-TEC TEST KIT	Calbiochem-Behring Corp.	1979-09-04	42
K791117	RABBIT COMPLEMENT	Calbiochem-Behring Corp.	1979-08-03	49
K791118	HLA CONTROL SERA	Calbiochem-Behring Corp.	1979-08-03	49
K790997	ANTI-DNASE B REAGENT SYSTEM	Calbiochem-Behring Corp.	1979-07-24	56
K790911	RIA OF PROGESTERONE	Calbiochem-Behring Corp.	1979-06-27	44
K790773	ENZYMATIC TRIGLYCERIDES-S.V.R.	Calbiochem-Behring Corp.	1979-06-15	56
K790460	TXOCELL-IHA REAGENT SYSTEM	Calbiochem-Behring Corp.	1979-05-25	81
K790556	CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC	Calbiochem-Behring Corp.	1979-05-07	49
K790280	AUTOANTIBODY REAGENTS, AFT SYSTEM II	Calbiochem-Behring Corp.	1979-04-23	69
K790330	CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN	Calbiochem-Behring Corp.	1979-03-15	27
K790012	RHEUMOGEN TEST SYSTEM	Calbiochem-Behring Corp.	1979-01-26	24
K781996	ACID REAGENT, URIC SINGLE VIAL	Calbiochem-Behring Corp.	1979-01-03	35
K781527	RIA SYSTEM FOR HUMAN FE-RITIN	Calbiochem-Behring Corp.	1978-10-03	28
K780870	RIA SYSTEM FOR HUMAN F-S HORMONE	Calbiochem-Behring Corp.	1978-06-22	23
K780367	RIA SYS. FOR HUMAN LUTEINIZING HORMONE	Calbiochem-Behring Corp.	1978-04-28	52
K780347	RIA SYS. FOR HUMAN GROWTH HORMONE	Calbiochem-Behring Corp.	1978-04-12	41

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda