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

Harleco Diagnostics — Predicate Candidate Screening

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

19 daysmedian FDA review time

33 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K823147	URIC ACID STANDARD, 8MG/DL #65078	Harleco Diagnostics	1982-11-22	28
K822852	TRIGLYCERIDE CALIBRATOR	Harleco Diagnostics	1982-10-27	33
K822323	ULTRACHEM BUN-UV, 65080 & 65081	Harleco Diagnostics	1982-09-02	30
K821873	ULTRACHEM T-BILI	Harleco Diagnostics	1982-07-14	19
K821871	ULTRAZYME PLUS 2GT	Harleco Diagnostics	1982-07-14	19
K821879	ULTRACHEM T.P.	Harleco Diagnostics	1982-07-14	19
K821883	ULTRAZYME PLUS CK-I	Harleco Diagnostics	1982-07-14	19
K821877	ULTRAZYME PLUS HBD	Harleco Diagnostics	1982-07-14	19
K821880	ULTRA CHEM ALB	Harleco Diagnostics	1982-07-14	19
K821881	ULTRACHEM CREA	Harleco Diagnostics	1982-07-14	19
K821882	ULTRAZYME PLUS GPT	Harleco Diagnostics	1982-07-14	19
K821878	ULTRAZYME PLUS LDH	Harleco Diagnostics	1982-07-14	19
K821872	ULTRACHEM URIC ACID AIDH	Harleco Diagnostics	1982-07-14	19
K821870	ULTRAZYME PLUS ALP	Harleco Diagnostics	1982-07-13	18
K821875	ULTRACHEM TRI-ES	Harleco Diagnostics	1982-07-13	18
K821876	ULTRAZYME PLUS GOT	Harleco Diagnostics	1982-07-13	18
K821869	ULTRAZYME PLUS AMYL	Harleco Diagnostics	1982-07-13	18
K821874	ULTRACHEM PHOS	Harleco Diagnostics	1982-07-13	18
K821868	ULTRACHEM E-GLU	Harleco Diagnostics	1982-07-08	13
K821867	ULTRACHEM GLUC-DH	Harleco Diagnostics	1982-07-06	11
K770694	CPK ULTRAZYME PLUS	Harleco Diagnostics	1977-07-01	77
K770613	LDH ULTRAZYME PLUS	Harleco Diagnostics	1977-06-17	78
K761026	AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL	Harleco Diagnostics	1976-11-30	18

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