ERYTHROCYTE TEST
FDA 510(k) clearance K832771 · decided 1983-10-28
Clearance details
- K-number
- K832771
- Device name
- ERYTHROCYTE TEST
- Applicant
- Bio-Analytics Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-16
- Decision date
- 1983-10-28
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- LKZ
- Device class
- 2
- Regulation number
- 864.7100
- 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 |
|---|---|---|
| COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (K833708) | Worthington Diagnostic Systems | 1984-01-04 |
Recalls involving this device
No recalls on record reference this clearance.