SAFECRIT PLASTIC MICROHEMATOCRIT TUBES
FDA 510(k) clearance K883185 · decided 1988-08-18
Clearance details
- K-number
- K883185
- Device name
- SAFECRIT PLASTIC MICROHEMATOCRIT TUBES
- Applicant
- Norfolk Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-28
- Decision date
- 1988-08-18
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- GHY
- Device class
- 2
- Regulation number
- 864.6400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Norwood, MA, 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 |
|---|---|---|
| MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL (K881186) | Helps Products, Inc. | 1988-05-13 |
Recalls involving this device
No recalls on record reference this clearance.