Precision Biologicals, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Precision Biologicals, Inc.” (first 1989, latest 1999), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 125 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | 7 | 7 |
| GGN | Plasma, Coagulation Control | 6 | 6 |
| GGC | Control, Plasma, Abnormal | 2 | 2 |
| JSM | Culture Media, Non-Propagating Transport | 2 | 2 |
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
Review panels
- Hematology (18)
- Microbiology (2)
Most recent Precision Biologicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | GGW | 1999-01-13 | 212 |
| K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | GJT | 1999-01-13 | 287 |
| K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | GJT | 1999-01-13 | 287 |
| K971219 | CRYO CHECK INR VALIDATION SET | GGN | 1997-08-29 | 149 |
| K971222 | CRYO CHECK APC RESISTANT PLASMA | GGN | 1997-08-19 | 139 |
| K971223 | CRYO CHECK FACTOR V DEFICIENT PLASMA | GJT | 1997-07-22 | 111 |
| K971227 | CRYO CHECK FACTOR X DEFICIENT PLASMA | GJT | 1997-07-18 | 107 |
| K971226 | CRYO CHECK FACTOR IX DEFICIENT PLASMA | GJT | 1997-07-18 | 107 |
| K971225 | CRYO CHECK FACTOR VIII DEFICIENT PLASMA | GJT | 1997-07-17 | 106 |
| K971224 | CRYO CHECK FACTOR VII DEFICIENT PLASMA | GJT | 1997-07-17 | 106 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Precision Biologicals, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Precision Biologicals, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Precision Medical, Inc. (30 510(k)s)
- Precision Dynamics Corp. (26 510(k)s)
- Precision Spine, Inc. (26 510(k)s)
- Precision Biologic (17 510(k)s)
- Precision Med Products, Ltd. (16 510(k)s)
- Precision Acoustics Ind., Inc. (9 510(k)s)
- Precision Cap Systems (7 510(k)s)
- Precision Vascular Systems, Inc. (7 510(k)s)
- Precision Instruments, Inc. (4 510(k)s)
- Precision Laser Products, Inc. (4 510(k)s)
- Precision Medical Instruments, Inc. (4 510(k)s)
- Precision Therapy Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Precision Biologicals, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Precision Biologicals, Inc.” (first 1989, latest 1999), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Precision Biologicals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Precision Biologicals, Inc. is 125 days.
Which FDA product codes appear under Precision Biologicals, Inc.?
The most frequent FDA product codes under this applicant name are GJT (Plasma, Coagulation Factor Deficient, 7); GGN (Plasma, Coagulation Control, 6); GGC (Control, Plasma, Abnormal, 2).
Next steps
- See all 20 Precision Biologicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GJT, Precision Biologicals, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.