AUSTIN NONFERMENTER KIT
FDA 510(k) clearance K870769 · decided 1987-04-03
Clearance details
- K-number
- K870769
- Device name
- AUSTIN NONFERMENTER KIT
- Applicant
- Austin Biological Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-02-26
- Decision date
- 1987-04-03
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- JSW
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Austin, TX, 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 |
|---|---|---|
| RAPID NFT, MODIFICATION (K922768) | Biomerieux Vitek, Inc. | 1992-10-14 |
| RAPID NF SYSTEM (K900517) | Innovative Diagnostic Systems, Inc. | 1990-03-13 |
| PSEUDO-PALETTE TM (K790992) | Micro-Palettes, Inc. | 1979-06-22 |
| NON-FERMENTER SYSTEM (K772112) | Corning Medical & Scientific | 1977-11-17 |
| PANEL, GNF, MICRO-ID (K770745) | Micro-Media Systems, Inc. | 1977-06-23 |
Recalls involving this device
No recalls on record reference this clearance.