Universal Reagents, Inc.: FDA clearances and approvals
Universal Reagents, Inc. has 8 FDA 510(k) clearances (first 1996, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time: 48 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 5 | 5 |
| GJT | Plasma, Coagulation Factor Deficient | 3 | 3 |
Review panels
- Hematology (8)
Most recent Universal Reagents, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973143 | UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA | GGP | 1997-09-25 | 34 |
| K972288 | FACTOR DEFICIENT PLASMAS - FACTOR IX (9) | GGP | 1997-07-14 | 25 |
| K972286 | FACTOR DEFICIENT PLASMAS - FACTOR XI (11) | GJT | 1997-07-14 | 25 |
| K970607 | UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA | GJT | 1997-04-25 | 66 |
| K970593 | UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA | GJT | 1997-04-25 | 66 |
| K964459 | UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA | GGP | 1996-12-18 | 41 |
| K964270 | UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA | GGP | 1996-12-18 | 54 |
| K961929 | FACTOR DEFICIENT PLASMA | GGP | 1996-10-10 | 146 |
Recalls
openFDA lists no recalls under a recalling firm named Universal Reagents, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Universal Reagents, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Universal Reagents, Inc. have?
Universal Reagents, Inc. has 8 FDA 510(k) clearances (first 1996, latest 1997), across 2 product codes in 1 review panel.
How long does FDA take to clear Universal Reagents, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Universal Reagents, Inc.'s cleared 510(k)s is 48 days.
What devices does Universal Reagents, Inc. make?
Its most frequent FDA product codes are GGP (Test, Qualitative And Quantitative Factor Deficiency, 5); GJT (Plasma, Coagulation Factor Deficient, 3).
Has Universal Reagents, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Universal Reagents, Inc. Related entities may recall under other names.
Next steps
- See all 8 Universal Reagents, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GGP, Universal Reagents, 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.