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

Immunoprobe, Inc. — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

203 daysmedian FDA review time
253 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMImmunoprobe, Inc.1997-12-221790
K971393MYCOPLASMA IGG ELISA TEST SYSTEMImmunoprobe, Inc.1997-07-14960
K961765MPO ELISA TEST SYSTEMImmunoprobe, Inc.1996-08-191040
K961764PR-3 ELISA TEST SYSTEMImmunoprobe, Inc.1996-08-191040
K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, Inc.1996-04-293910
K952523CARDIOLIPIN IGG EIA TEST KITImmunoprobe, Inc.1996-02-092530
K952521CARDIOLIPIN IGM EIA TEST SYSTEMImmunoprobe, Inc.1996-02-092530
K952522CARDIOLIPIN IGA EIA TEST SYSTEMImmunoprobe, Inc.1996-02-092530
K951362THYROGLOBULIN EIA TEST KITImmunoprobe, Inc.1995-11-202410
K951364MICROSOMAL EIA TEST KITImmunoprobe, Inc.1995-11-202410
K951363CARDIOLIPIN IGG,M,A EIA TEST SYSTEMImmunoprobe, Inc.1995-10-132030
K952520CARDIOLIPIN IGG,M,A EIA TEST KITImmunoprobe, Inc.1995-09-151060
K941361MICROSOMAL EIA TEST KITImmunoprobe, Inc.1994-05-11510
K941358THYROGLOBULIN EIA TEST KITImmunoprobe, Inc.1994-05-11510

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