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

Harleco — Predicate Candidate Screening

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

25 daysmedian FDA review time

68 days90th percentile

116clearances measured

K-number	Device	Applicant	Decided	Review days
K820233	ULTRAZYME PLUS GAMMA GT(65055-65056)	Harleco	1982-02-12	15
K813427	ULTRACHEM GLUC-DH	Harleco	1981-12-31	24
K813040	ULTRACHEM CA, ITEM #64975	Harleco	1981-11-10	13
K813044	ULTRACHEM ALB, ITEM #64970	Harleco	1981-11-10	13
K813039	ULTRACHEM E-CHOL, ITEM #65025	Harleco	1981-11-10	13
K813038	ULTRACHEM TP, ITEM #64974	Harleco	1981-11-10	13
K813043	ULTRACHEM CREA ITEM #64972	Harleco	1981-11-10	13
K813041	ULTRAZYME-GT, ITEM #64959 & 65032	Harleco	1981-11-10	13
K813042	ULTRACHEM GLUC-DH SET, ITEM #65048	Harleco	1981-11-10	13
K812594	ULTRA ZYME PLUS AMYL #64982 & 65031	Harleco	1981-10-02	21
K812593	ULTRA ZYME PLUS CK-1 #64978, 65027 & 28	Harleco	1981-10-02	21
K812595	ULTRA CHEM E-GLU #64976 & 65040	Harleco	1981-09-29	18
K812596	ULTRA ZYME PLUS ALP #64962, 65029 & 30	Harleco	1981-09-29	18
K812592	ULTRA ZYME PLUS GOT #64953, 65033 & 34	Harleco	1981-09-24	13
K812591	ULTRA ZYME PLUS GPT, #64956, 65035 & 36	Harleco	1981-09-24	13
K812590	ULTRA ZYME PLUS LDH #64950, 65038 & 39	Harleco	1981-09-24	13
K812589	ULTRA CHEM E-TRIG #65024	Harleco	1981-09-24	13
K812500	ULTRACHEM URIC ACID ALDH, ITEM #65047	Harleco	1981-09-23	23
K812258	ACR ENZYMATIC GLUCOSE OXIDASE	Harleco	1981-08-31	19
K811573	CARDIOZYME PLUS CK-MB ITEM #65045	Harleco	1981-06-25	21
K811574	CARDIOZYME PLUS CK-TOTAL ITEM #65046	Harleco	1981-06-25	21
K811575	CARDIOZYME PLUS CK-MB ITEM #65045 (G)	Harleco	1981-06-25	21
K811576	CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)	Harleco	1981-06-25	21
K811202	ULTRACHEM GLUC-DH, ITEM NO. 65048	Harleco	1981-05-27	26
K810684	HEMOCOLOR STAIN SET	Harleco	1981-04-08	26
K810725	QUALITROL #65057	Harleco	1981-03-31	14
K803169	CARDIOZYME PLUS CK-TOTAL #65046	Harleco	1981-01-09	25
K803168	CARDIO ZYME PLUS CK-MB #65045	Harleco	1981-01-09	25
K780829	SYSING AND HEMOGLOBIN REAGENT	Harleco	1978-06-22	34
K780830	ISOTONIC BUFFERED SALINE	Harleco	1978-06-14	26
K780523	ULTRACHEM ENZYMATIC CHOLESTEROL 65025	Harleco	1978-05-19	49
K780524	ULTRACHEM T-BILI 64971 GILFORD 3500	Harleco	1978-05-19	49
K780515	ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM	Harleco	1978-05-19	50
K780513	ULTRA ZYME PLUS AMYL 64982, GILFORD 3500	Harleco	1978-05-19	50
K780514	ULTRACHEM CREATININE 64972, CENTRIFUCHEM	Harleco	1978-05-19	50
K780141	ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.	Harleco	1978-03-09	42
K780099	ULTRAZYME PLUS GT	Harleco	1978-03-09	48
K780172	TRIGLYCERIDE INSTRUMENT APPLICATION	Harleco	1978-03-09	35
K780100	ULTRAZYME PLUS CK-1	Harleco	1978-03-09	48
K780101	ULTRAZYME PLUS LDH	Harleco	1978-02-14	25
K780103	ULTRAZYME PLUS GOT	Harleco	1978-02-13	24
K780104	ULTRAZYME PLUS HBD	Harleco	1978-02-13	24
K780102	ULTRAZYME PLUS GPT	Harleco	1978-02-13	24
K780095	ULTRAZYME PLUS ALP	Harleco	1978-02-13	26
K780094	IRON BINDING CAPACITY CHEMISTRY	Harleco	1978-02-13	26
K780093	GLUCOSE REAGENT FOR GLUCOSE ANALYZER	Harleco	1978-02-13	26
K780092	ULTRACHEM ALBUMIN	Harleco	1978-02-07	20
K780065	ULTRACHEM E-GLU, MANUAL DETERM.	Harleco	1978-02-01	20
K772258	CLINICARD CK-II	Harleco	1978-01-05	27
K772156	ULTRACHEM PHOSPHORUS, 64973	Harleco	1977-12-06	20

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