MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
FDA 510(k) clearance K881186 · decided 1988-05-13
Clearance details
- K-number
- K881186
- Device name
- MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
- Applicant
- Helps Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-21
- Decision date
- 1988-05-13
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- GHY
- Device class
- 2
- Regulation number
- 864.6400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Orlando, FL, 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 |
|---|---|---|
| SAFECRIT PLASTIC MICROHEMATOCRIT TUBES (K883185) | Norfolk Scientific, Inc. | 1988-08-18 |
Recalls involving this device
No recalls on record reference this clearance.