MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT
FDA 510(k) clearance K943051 · decided 1995-03-13
Clearance details
- K-number
- K943051
- Device name
- MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT
- Applicant
- Dynagen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-27
- Decision date
- 1995-03-13
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- JSY
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cambridge, MA, 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 |
|---|---|---|
| MYCOAKT M. AVIUM CULTURE ID KIT (K943049) | Dynagen, Inc. | 1995-03-13 |
| MYCOAKT M KANSASII CULTURE ID KIT (K943050) | Dynagen, Inc. | 1995-03-13 |
| ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION (K880990) | Alpha-Tec Systems, Inc. | 1988-03-24 |
| API TB-IDENT* (K830211) | Analytical Products, Inc. | 1983-03-24 |
Recalls involving this device
No recalls on record reference this clearance.