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

LKL — Predicate Candidate Screening

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

57 daysmedian FDA review time

184 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K993441	K-ASSAY ALPHA-1 AG	Kamiya Biomedical Co.	1999-11-24	43
K964299	N-ASSAY TIA MULTI V-NL	Crestat Diagnostics, Inc.	1997-07-14	258
K964257	IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG	Beckman Instruments, Inc.	1997-03-24	150
K922417	AL-ACID GLYCOPROTEIN RID KIT	The Binding Site, Ltd.	1992-08-20	91
K904175	RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT	Reagents Applications, Inc.	1990-11-13	63
K884217	TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN	Technicon Instruments Corp.	1988-11-04	23
K873868	ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)	Unipath , Ltd.	1987-10-20	57
K862087	SANTEST 1AP	Scientific Sales Intl., Inc.	1986-12-03	184
K861336	IAP PLATE TEST	Scientific Sales Intl., Inc.	1986-04-25	16
K841734	TAGO FIFFU-GEN, OROSOMUCOID	Tago, Inc.	1984-06-01	36
K831960	TEST FOR HUMAN ALPHA ONE ACID GLYCO-	Kent Laboratories, Inc.	1983-07-19	32

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