Atlas FDA

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

Metra Biosystems, Inc. — Predicate Candidate Screening

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

120 daysmedian FDA review time
225 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K981364PYRILINKS-D ASSAY KITMetra Biosystems, Inc.1998-08-131200
K981373ALKPHASE-B ASSAY KITMetra Biosystems, Inc.1998-05-27410
K974260PYRILINKS-D ASSAY KITMetra Biosystems, Inc.1998-01-26740
K952320PYRILINKS-D ASSAY KITMetra Biosystems, Inc.1995-12-292250
K952506PYRILINKS ASSAY KITMetra Biosystems, Inc.1995-11-031560
K952026PYRILINKS POLYCLONAL ASSAY KITMetra Biosystems, Inc.1995-11-031860
K952768ALKPHASE-B ASSAY KITMetra Biosystems, Inc.1995-08-24710

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