CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
FDA 510(k) clearance K881242 · decided 1988-04-21
Clearance details
- K-number
- K881242
- Device name
- CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
- Applicant
- Abbott Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1988-03-16
- Decision date
- 1988-04-21
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GJZ
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mountain View, CA, 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 |
|---|---|---|
| HEMOGLOBIN (K883683) | Tech-Co, Inc. | 1988-10-06 |
Recalls involving this device
No recalls on record reference this clearance.