LUMI-AGGREGOMETER
FDA 510(k) clearance K771198 · decided 1977-08-02
Clearance details
- K-number
- K771198
- Device name
- LUMI-AGGREGOMETER
- Applicant
- Chrono-Log Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-07-01
- Decision date
- 1977-08-02
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- JBY
- Device class
- 2
- Regulation number
- 864.6675
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Havertown, PA, 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 |
|---|---|---|
| PACKS-4 (TM) ANALYZER (K912201) | Helena Laboratories | 1991-08-16 |
Recalls involving this device
No recalls on record reference this clearance.