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

CJA — Predicate Candidate Screening

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

61 daysmedian FDA review time

107 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K895555	MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)	Hichem Diagnostics	1989-12-22	107
K884226	AMYLASE REAGENT KIT FOR ASTRA SYSTEMS	A-Kem, Inc.	1988-12-09	64
K883059	WAKO(TM) AUTOKIT AMYLASE	Wako Chemicals USA, Inc.	1988-08-30	42
K873520	PARAMAX AMYLASE REAGENT	Baxter Healthcare Corp	1987-11-23	83
K863052	ALPHA AMYLASE	J. D. Assoc.	1986-09-09	28
K862640	AMYLASE LTS	Electro-Nucleonics Laboratories, Inc.	1986-09-09	61
K860530	AMYLASE REAGENT SET (MODIFIED CARAWAY)	Sterling Diagnostics, Inc.	1986-02-28	16
K844168	AMYLASE REAGENT CS-726	Fisher Scientific Co., LLC	1984-11-20	26
K843529	ASTRA SYSTEMS AMYLASE REAGENT KIT	Beckman Instruments, Inc.	1984-10-11	34
K833864	AMYLASE REAGENT SET-MODIFIED CARAWAY	Sterling Biochemical, Inc.	1984-01-13	67

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