ACCUVETTE II
FDA 510(k) clearance K760197 · decided 1976-07-19
Clearance details
- K-number
- K760197
- Device name
- ACCUVETTE II
- Applicant
- Coulter Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-07-06
- Decision date
- 1976-07-19
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- JRI
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| MEDATRON CUVETTE DISC (K873656) | Medatron, Inc. | 1987-12-14 |
| THERMO SET ELECTRONIC TEM. CONTROLLER (K780888) | Gilford Instrument Laboratories, Inc. | 1978-06-28 |
| TEMPERATURE REGULATED FIVE CELL HOLDERS (K760769) | The Perkin-Elmer Corp. | 1976-11-30 |
Recalls involving this device
No recalls on record reference this clearance.