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

JBD · Predicate Candidate Screening

26 FDA 510(k) clearances under this product code; the 50 most recent screened below.

42 daysmedian FDA review time

144 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K053571	MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MI	Interlab S.R.L.	2006-06-30	190	0
K032862	INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM	Interlab S.R.L.	2004-02-03	144	0
K992199	ACID HEMOGLOBIN KIT	Helena Laboratories	1999-09-21	83	0
K991362	HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E),	Morax	1999-06-21	68	1
K982426	SPIFE ALKALINE HEMOGLOBIN	Helena Laboratories	1998-12-17	157	0
K931503	REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)	Helena Laboratories	1993-08-16	144	0
K931465	REP ALKALINE HB-15 #3196,-8 #3197,-4 3198	Helena Laboratories	1993-07-06	104	0
K901143	REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)	Helena Laboratories	1990-05-23	72	0
K830804	LABILE REMOVING HEMOLYZING REAGENT	Corning Medical & Scientific	1983-05-04	51	0
K820518	GELMAN GLYCO-PHORE BUFFER	Gelman Sciences, Inc.	1982-04-09	43	0
K813395	CELLULOSE ACETATE-CITRATE AGAR HEMOGLO	Helena Laboratories	1981-12-31	27	0
K810919	HEMOGLOBIN ELECTROPHORESIS CONTROL	Isolab, Inc.	1981-04-23	17	0
K810047	AUTOPHOR 128	Gelman Sciences, Inc.	1981-02-05	24	0
K802884	CORNING NORMAL GLYCOSYLATED HEMOGLOBIN	Corning Medical & Scientific	1980-12-22	35	0
K802821	PARAGON HEMOGLOBIN ELECTRO. REAG. KIT	Beckman Instruments, Inc.	1980-12-11	31	0
K800853	A,SA2 LYOPHILIZED HEMO CONTROL	Helena Laboratories	1980-04-29	14	0
K800856	A,FDA2 LYOPHILIZED HEMO CONTROL	Helena Laboratories	1980-04-29	14	0
K800854	A,A2 LYOPHILIZED HEMO CONTROL	Helena Laboratories	1980-04-29	14	0
K800855	A,FSC LYOPHILIZED HEMO CONTROL	Helena Laboratories	1980-04-29	14	0
K791290	BECKMAN B-4 TEB BUFFER KIT	Beckman Instruments, Inc.	1979-08-03	24	0
K791008	ECA (SPECIAL) HEME BUFFER	Electrophoresis Corp. of America	1979-08-03	64	0
K790944	CITRATE AGAR GEL AND BUFFER SET	Corning Medical & Scientific	1979-06-28	41	0
K781119	ECA HEME BUFFER	Electrophoresis Corp. of America	1978-08-14	42	0
K780807	HBF-QUIPLATE METHODOLOGY	Helena Laboratories	1978-06-02	29	0
K780163	REDI-DISC HEMOGLOBIN GEL TUBE KIT	Miles Laboratories, Inc.	1978-03-27	55	0
K771649	HEMOGLOBIN A2 TESTING SYSTEM	Isolab, Inc.	1977-10-07	39	0

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