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

LKH — Predicate Candidate Screening

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

63 daysmedian FDA review time

413 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K910644	IPAZYME (TM) CHLAMYDIA IGG-IGA	Savyon Diagnostics , Ltd.	1991-03-19	33
K901975	IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)	Savyon Diagnostics , Ltd.	1991-03-08	311
K882674	IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT	Icn Immunobiologicals	1989-08-15	413
K893669	CELLMATICS SHLAMYDIA DETECTION SYSTEM	Difco Laboratories, Inc.	1989-06-23	39
K852869	SELECTICULT-CHLAMYDIA	Scott Laboratories, Inc.	1985-09-19	73
K842151	CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT	Bartels Immunodiagnostic Supplies, Inc.	1984-07-20	51
K830688	COMBION SKIN TEST	Nicholas H. Maganias	1983-03-31	27
K820390	HISTOSET IMMUNOPEROXIDASE TISSURE KIT	Immulok, Inc.	1982-04-14	63

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