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

CZN — Predicate Candidate Screening

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

35 daysmedian FDA review time

123 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K891683	TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER	Helena Laboratories	1989-04-12	21
K855011	QUANTIMETRIC PLUS C3 REAGENT KIT	Kallestad Laboratories, Inc.	1986-02-26	72
K841815	OPTIMATE IGA TEST	Miles Laboratories, Inc.	1984-06-01	31
K832262	FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS	Gelco Diagnostics, Inc.	1983-10-31	123
K832257	GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC	Gelco Diagnostics, Inc.	1983-10-28	120
K831909	RABBIT ANTISERUM TO HUMAN IGA	Dako Corp.	1983-07-18	34
K831607	FIAX IGA TEST KIT	Intl. Diagnostic Technology	1983-06-22	35

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