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

CFE — Predicate Candidate Screening

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

42 daysmedian FDA review time

122 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days
K100307	GELSCAN, MODEL 1206	Sebia	2010-08-31	209
K022455	SPIFE LD-12 KIT, MODEL 3338	Helena Laboratories	2002-10-01	67
K020467	SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452	Helena Laboratories	2002-03-29	45
K970477	HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT	Sebia	1997-03-10	31
K940224	CARDIO REP LD	Helena Laboratories	1994-08-17	211
K921455	ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD	E.I. Dupont DE Nemours & Co., Inc.	1992-04-29	33
K905861	ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH	E.I. Dupont DE Nemours & Co., Inc.	1991-02-06	37
K894081	ROCHO ISOMUNE - LD	Roche Diagnostic Systems, Inc.	1989-08-31	84
K892818	REP(TM) LD-2 STAT KIT, CAT. NO. 3078	Helena Laboratories	1989-06-20	64
K874142	TITAN GEL REP LDH-30 HV	Helena Laboratories	1987-11-24	42
K874145	TITAN GEL REP LDH-6 HV	Helena Laboratories	1987-11-24	42
K874143	TITAN GEL REP LDH-12 HV	Helena Laboratories	1987-11-23	41
K873386	TITAN GEL LDH REP SYSTEM	Helena Laboratories	1987-10-20	57
K861750	CK/LD BUFFER (CAT. NO. 5808)	Helena Laboratories	1986-05-29	23
K850210	ISOENZYME TEST LD-1	Sclavo, Inc.	1985-03-29	73
K842669	TITAN GEL ISO DOT LDH KIT	Helena Laboratories	1984-11-09	122
K841433	CORNING LACTATE DEHYDROPHORETIC ASSAY	Corning Medical & Scientific	1984-05-16	40
K832314	CARDIZYME PLUS LD #65094/93	Em Industries, Inc.	1983-09-01	49
K830872	TITAN GEL LDH ISO-ENZYME CONTROL	Helena Laboratories	1983-04-12	25
K802628	PARAGON ELECTROPHORESIS LACTATE REAG.KIT	Beckman Instruments, Inc.	1980-12-11	49
K800568	TRANSPHOR TM LD LACTATE DEHYDROGENASE	Corning Medical & Scientific	1980-04-04	22
K791373	ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS	Hoffmann-La Roche, Inc.	1979-10-26	94
K791827	LDH CLINI GEL KIT	Clinical Sciences, Inc.	1979-10-01	14
K791656	ENZYME STABILIZING REAGENT (ESR)	Electrophoresis Corp. of America	1979-09-17	27
K791657	LDH ISOENZYME REAGENT	Electrophoresis Corp. of America	1979-09-17	27
K790311	LDH ISOENZYME REAGENT	Electrophoresis Corp.	1979-03-21	36
K781125	LDH ISOENZYME REAGENT	Electrophoresis Corp. of America	1978-08-10	38
K780080	LACTATE DEHYDROGENASE COLORIMETRIC SUB.	Corning Medical & Scientific	1978-02-07	22

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