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

JHS — Predicate Candidate Screening

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

39 daysmedian FDA review time

74 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K160570	Creatine Kinase	Roche Diagnostics Operations (Rdo)	2016-05-25	86	1
K102706	CKMB UDR ASSAY	SENTINEL CH. SpA	2011-08-19	333	0
K082226	S40 CREATINE KINASE (CK)	Alfa Wassermann Diagnostic Technologies, Inc.	2008-09-18	42	0
K062128	THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS	Dade Behring, Inc.	2006-08-21	26	0
K990439	CARESIDE CK	Careside, Inc.	1999-04-19	67	0
K990434	CARESIDE CKMB	Careside, Inc.	1999-04-19	67	0
K981495	IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TEST	Diagnostic Products Corp.	1998-06-10	44	0
K962126	ACS CKMB II IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1996-06-21	18	0
K952250	STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & ST	Dade Intl., Inc.	1995-07-17	63	0
K945083	ACCESS CK-MB REAGENTS	Bio-Rad Laboratories, Inc.	1994-11-21	35	0
K943024	KINASE ISOENZYME	Dupont Medical Products	1994-08-02	68	0
K941584	CREATINE KINASE METHOD	Dupont Medical Products	1994-07-06	96	0
K903025	ROCHE ISOMUNE- CK	Roche Diagnostic Systems, Inc.	1990-08-09	30	0
K900806	STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY	Baxter Healthcare Corp	1990-03-23	30	0
K883223	CHECK-MM	Intl. Immunoassay Laboratories, Inc.	1988-09-30	63	0
K872029	UNI-FAST CREATINE KINASE TEST (CK)	Sclavo, Inc.	1987-06-17	22	0
K861387	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)	Eastman Kodak Company	1986-06-27	74	2
K855188	CPK (UV) REAGENT KIT	Technostics Intl.	1986-03-05	69	0
K854708	DART CK-MB REAGENT SYSTEM	Coulter Electronics, Inc.	1985-12-30	38	0
K843007	CARDI-CK EIA TEST KIT CK-MB ISOENZYME	Intl. Immunoassay Laboratories, Inc.	1984-09-07	38	0
K823211	CK-UV REAGENT	Biorent Diagnostic, Inc.	1982-11-22	25	0
K820722	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE	Eastman Kodak Company	1982-04-01	16	0
K813406	CPK(CK) IN VITRO DIAG. REAGENT SET	Pointe Scientific, Inc.,	1981-12-22	15	0
K810997	WORTHINGTON CK (NAC) REAGENT SET	Worthington Diagnostic Systems	1981-04-23	10	0
K803169	CARDIOZYME PLUS CK-TOTAL #65046	Harleco	1981-01-09	25	0
K802521	CK-MB(IMMUNOLOGICAL)	Biodynamics Corp.	1980-11-12	28	0
K801668	QUICK CEPT	Laboratory Diagnostics Co., Inc.	1980-08-13	23	0
K800028	WORTHINGTON FLOZYME* CPK (340NM)	Worthington Diagnostic Systems	1980-01-21	14	0
K792023	ESKACHEM, CK-MB REAGENT	Smithkline Diagnostics, Inc.	1979-10-30	21	0
K790917	SPIN CHEM CK-NAC REAGENT	Smithkline Diagnostics, Inc.	1979-06-22	39	0
K790918	ESKLAB REAGENT TABLETS	Smithkline Diagnostics, Inc.	1979-06-22	39	0
K790916	CK-NUC REAGENT	Smithkline Diagnostics, Inc.	1979-06-22	39	0
K790343	DATA-ZYME CK CALORIMETRIC/UV PROCEDURE	Data Medical Associates, Inc.	1979-05-01	69	0
K790088	ACA CREATINE KINASE ISOENZYMES	E.I. Dupont DE Nemours & Co., Inc.	1979-03-12	55	0
K790015	SERUM, CREATININE PHOSPHOKINASE	Fisher Scientific Co., LLC	1979-02-15	43	0
K781690	L-CYSTEINE HYDROCHLORIDE	Fisher Scientific Co., LLC	1978-10-27	23	0
K781432	STAT ULTRA VIOLET LIQUID	Beckman Instruments, Inc.	1978-10-03	43	0
K780504	CREATINE PHOSPHOKINASE (CPK)	Gamma Enterprises, Inc.	1978-05-03	34	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