Product code JTL
- Device name
- Plasma, Coagulase, Human, Horse And Rabbit
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2160
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950706 | DRYSLIDE COAGULASE | Difco Laboratories, Inc. | 1995-05-16 |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | Immuno-Mycologics, Inc. | 1988-08-25 |
| K870945 | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 | Oxoid U.S.A., Inc. | 1987-06-10 |
| K861312 | LYFO-KWIK (TM) COAGULASE PLASMA | Micro-Bio-Logics | 1986-04-18 |
| K840553 | HEMASTAPH | Remel Co. | 1984-04-13 |
| K833988 | API STAPHASE III | Analytical Products, Inc. | 1983-12-22 |
| K833858 | COAGULASE PLASMA, HORSE & RABBIT EDTA | Otisville Biotech, Inc. | 1983-12-08 |
| K822988 | COAGULASE PLASMA-CITRATED & EDTA | American Scientific Products | 1982-11-05 |
| K820177 | COAGULASE PLASMA | Quadroma, Inc. | 1982-02-05 |
| K812602 | RABBIT COAGULASE PLASMA | Dutchland Laboratories, Inc. | 1981-09-29 |
| K811982 | STAPHASE* | Analytical Products, Inc. | 1981-07-28 |
| K792235 | COAGULASE PLASMA | Remel Co. | 1979-12-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00848838022227 | REMEL | REMEL, INC. | 2023-01-03 |
| 00848838022241 | REMEL | REMEL, INC. | 2023-01-03 |
| 00848838022258 | REMEL | REMEL, INC. | 2023-01-03 |
| 00848838022265 | REMEL | REMEL, INC. | 2023-01-03 |
| 05060472467515 | Rabbit Coagulase Plasma (10x3ml) | PRO-LAB, INCORPORATED | 2022-12-20 |
| 05060472467522 | Rabbit Coagulase Plasma (1x10ml) | PRO-LAB, INCORPORATED | 2022-12-20 |
| 05060472467539 | Rabbit Coagulase Plasma (1x20ml) | PRO-LAB, INCORPORATED | 2022-12-20 |
| 05060472467546 | Rabbit Coagulase Plasma (1x30ml) | PRO-LAB, INCORPORATED | 2022-12-20 |
| 00819398026581 | Coagulase Cryo™ | HARDY DIAGNOSTICS | 2020-08-06 |
| 00819398026574 | Coagulase Cryo™ | HARDY DIAGNOSTICS | 2020-08-06 |
| 00816576028221 | CoaguStaph™ | HARDY DIAGNOSTICS | 2020-06-25 |
| 00816576028214 | CoaguStaph™ | HARDY DIAGNOSTICS | 2020-06-25 |
| 00816576028191 | CoaguStaph™ | HARDY DIAGNOSTICS | 2020-06-25 |
| 00816576028207 | CoaguStaph™ | HARDY DIAGNOSTICS | 2020-06-25 |
| 30382902406588 | BD BBL™ Coagulase Plasma, Rabbit | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902406618 | BD BBL™ Coagulase Plasma, Rabbit | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902408261 | BD BBL™ Coagulase Plasma, Rabbit with EDTA | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902408278 | BD BBL™ Coagulase Plasma, Rabbit with EDTA | BECTON, DICKINSON AND COMPANY | 2018-05-25 |