BLEEDING TIME DEVICE DISPOSABLE
FDA 510(k) clearance K830645 · decided 1983-03-17
Clearance details
- K-number
- K830645
- Device name
- BLEEDING TIME DEVICE DISPOSABLE
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1983-03-01
- Decision date
- 1983-03-17
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- JCA
- Device class
- 2
- Regulation number
- 864.6100
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| SIMPLATE PEDIATRIC (K911745) | Organon Teknika Corp. | 1991-08-09 |
| SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION (K911996) | International Technidyne Corp. | 1991-07-17 |
| Q.I.C. BLEEDING TIME DEVICE (K871318) | Helena Laboratories | 1987-06-10 |
| SURGICUTT - BLEEDING TIME DEVICE (K850542) | International Technidyne Corp. | 1985-03-01 |
| AUTOLET (K801815) | Ulster Scientific, Inc. | 1980-10-10 |
| SIMPLATE (K761250) | General Diagnostics | 1977-03-01 |
Recalls involving this device
No recalls on record reference this clearance.