BIONOR TRANSPORTMEDIUM
FDA 510(k) clearance K925450 · decided 1993-06-25
Clearance details
- K-number
- K925450
- Device name
- BIONOR TRANSPORTMEDIUM
- Applicant
- Skoug Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-28
- Decision date
- 1993-06-25
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- JSL
- Device class
- 1
- Regulation number
- 866.2390
- 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 |
|---|---|---|
| COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (K972449) | Copan Italia Spa | 1997-08-20 |
| COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (K972448) | Copan Italia Spa | 1997-08-20 |
| KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM (K944847) | Starplex Scientific, Inc. | 1995-02-16 |
| ANAEROBIC TRANSPORT MEDIUM (K841220) | Anaerobe Systems | 1984-04-04 |
| ANA TRANS TUBE & SWABS STERILE PACK (K834357) | Anaerobe Systems | 1984-01-31 |
| PRE-REDUCED ANAEROBIC MEDIA (K770840) | Gibco Laboratories Life Technologies, Inc. | 1977-06-08 |
| PRE-DUCED CULTURE MEDIA (K770650) | Gibco Laboratories Life Technologies, Inc. | 1977-04-15 |
Recalls involving this device
No recalls on record reference this clearance.