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

JJI · Predicate Candidate Screening

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

58 daysmedian FDA review time

98 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K972024	CODA AUTOMATED EIA ANALYZER	Bio-Rad	1997-07-30	58
K944731	ABBOTT IMX 2 ANALYZER	Abbott Laboratories	1994-12-19	98
K931970	ABBOTT IMX2 ANALYER	Abbott Laboratories	1993-06-16	55
K930898	RADIAS AUTOMATED IMMUNOASSAY SYSTEM	Bio-Rad	1993-04-21	58
K790073	ANALYZER, IMPACT 100	Gilford Instrument Laboratories, Inc.	1979-02-22	42
K780972	QUICKRATE REACTION RATE ANALYZER	Olympus Corp.	1978-08-14	63
K771591	MINISTAT-S CHEMISTRY ANALYZER	Biokinetix Corp.	1977-09-20	32
K770401	LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1977-04-26	55

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