GIBCO MYCOTECT 189-5670
FDA 510(k) clearance K851275 · decided 1985-06-21
Clearance details
- K-number
- K851275
- Device name
- GIBCO MYCOTECT 189-5670
- Applicant
- Gibco Laboratories Life Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-01
- Decision date
- 1985-06-21
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- KIW
- Device class
- 1
- Regulation number
- 864.2360
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Grandisland, NY, 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 |
|---|---|---|
| GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) (K860695) | Gibco Laboratories Life Technologies, Inc. | 1986-03-12 |
Recalls involving this device
No recalls on record reference this clearance.