HEMASTAPH
FDA 510(k) clearance K840553 · decided 1984-04-13
Clearance details
- K-number
- K840553
- Device name
- HEMASTAPH
- Applicant
- Remel Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-08
- Decision date
- 1984-04-13
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- JTL
- Device class
- 1
- Regulation number
- 866.2160
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DRYSLIDE COAGULASE (K950706) | Difco Laboratories, Inc. | 1995-05-16 |
| RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT (K883333) | Immuno-Mycologics, Inc. | 1988-08-25 |
| RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 (K870945) | Oxoid U.S.A., Inc. | 1987-06-10 |
| LYFO-KWIK (TM) COAGULASE PLASMA (K861312) | Micro-Bio-Logics | 1986-04-18 |
| API STAPHASE III (K833988) | Analytical Products, Inc. | 1983-12-22 |
| COAGULASE PLASMA, HORSE & RABBIT EDTA (K833858) | Otisville Biotech, Inc. | 1983-12-08 |
| COAGULASE PLASMA-CITRATED & EDTA (K822988) | American Scientific Products | 1982-11-05 |
| COAGULASE PLASMA (K820177) | Quadroma, Inc. | 1982-02-05 |
| RABBIT COAGULASE PLASMA (K812602) | Dutchland Laboratories, Inc. | 1981-09-29 |
| STAPHASE* (K811982) | Analytical Products, Inc. | 1981-07-28 |
| COAGULASE PLASMA (K792235) | Remel Co. | 1979-12-07 |
Recalls involving this device
No recalls on record reference this clearance.