DISC-PAK ROTATOR
FDA 510(k) clearance K780544 · decided 1978-04-24
Clearance details
- K-number
- K780544
- Device name
- DISC-PAK ROTATOR
- Applicant
- Techhnilab Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-04-03
- Decision date
- 1978-04-24
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- GLE
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, 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 |
|---|---|---|
| IMS HEMATOLOGY MIXER (K823124) | Innovative Medical Systems, Inc. | 1982-11-22 |
| CORTEX DOUBLE HELIX SAMPLER (K800003) | Cortex Research Corp. | 1980-02-01 |
| SPECI-MIX (K771617) | Thermolyne Corp. | 1977-09-02 |
| PLATELET AGITATOR (K770830) | Helmer Labs, Inc. | 1977-07-11 |
Recalls involving this device
No recalls on record reference this clearance.