510(k) K870769
- Device
- AUSTIN NONFERMENTER KIT
- Applicant
- AUSTIN BIOLOGICAL LABORATORIES
- 510(k) number
- K870769
- Product code
- JSW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-04-03
- Date received
- 1987-02-26
- Regulation
- 866.2660
- Classification name
- Kit, Identification, Glucose Nonfermenter
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENNIS SCHNEIDER,PHD
- Address
- 6620-A Manor Rd. Austin TX US 78723 78723
FDA Registration Numbers#
- 1924669
- 3003750284
- 9615754
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K922768 | RAPID NFT, MODIFICATION | Biomerieux Vitek, Inc. | 1992-10-14 |
| K900517 | RAPID NF SYSTEM | Innovative Diagnostic Systems, Inc. | 1990-03-13 |
| K790992 | PSEUDO-PALETTE TM | Micro-Palettes, Inc. | 1979-06-22 |
| K772112 | NON-FERMENTER SYSTEM | Corning Medical & Scientific | 1977-11-17 |
| K770745 | PANEL, GNF, MICRO-ID | Micro-Media Systems, Inc. | 1977-06-23 |
Legacy Summary#
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FDA Review#
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