MINIFUGE, MODEL 70
FDA 510(k) clearance K882149 · decided 1988-07-01
Clearance details
- K-number
- K882149
- Device name
- MINIFUGE, MODEL 70
- Applicant
- Utah Bioresearch, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-23
- Decision date
- 1988-07-01
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- GPG
- Device class
- 1
- Regulation number
- 866.3850
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, 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 |
|---|---|---|
| TRICHINELLA SEROLOGY MICROTITER ELISA (K904613) | Lmd Laboratories | 1991-03-21 |
Recalls involving this device
No recalls on record reference this clearance.