Metra Biosystems, Inc.: FDA clearances and approvals
Metra Biosystems, Inc. has 7 FDA 510(k) clearances (first 1995, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time: 120 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JMM | Column Chromatography & Color Development, Hydroxyproline | 5 | 5 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 2 | 2 |
Review panels
Most recent Metra Biosystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981364 | PYRILINKS-D ASSAY KIT | JMM | 1998-08-13 | 120 |
| K981373 | ALKPHASE-B ASSAY KIT | CIN | 1998-05-27 | 41 |
| K974260 | PYRILINKS-D ASSAY KIT | JMM | 1998-01-26 | 74 |
| K952320 | PYRILINKS-D ASSAY KIT | JMM | 1995-12-29 | 225 |
| K952506 | PYRILINKS ASSAY KIT | JMM | 1995-11-03 | 156 |
| K952026 | PYRILINKS POLYCLONAL ASSAY KIT | JMM | 1995-11-03 | 186 |
| K952768 | ALKPHASE-B ASSAY KIT | CIN | 1995-08-24 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Metra Biosystems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Metra Biosystems, Inc. have?
Metra Biosystems, Inc. has 7 FDA 510(k) clearances (first 1995, latest 1998), across 2 product codes in 1 review panel.
How long does FDA take to clear Metra Biosystems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Metra Biosystems, Inc.'s cleared 510(k)s is 120 days.
What devices does Metra Biosystems, Inc. make?
Its most frequent FDA product codes are JMM (Column Chromatography & Color Development, Hydroxyproline, 5); CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, 2).
Has Metra Biosystems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Metra Biosystems, Inc. Related entities may recall under other names.
Next steps
- See all 7 Metra Biosystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JMM, Metra Biosystems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.