510(k) K923133
- Device
- AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS
- Applicant
- MICROPROBE CORP.
- 510(k) number
- K923133
- Product code
- MJM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-09-25
- Date received
- 1992-06-29
- Regulation
- 866.2660
- Classification name
- Dna Probe, Gardnerella Vaginalis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSEL K ENNS
- Address
- 1725 220th St., SE, 104 Bothell WA US 98021 98021
FDA Registration Numbers#
- 3012494290
- 2647876
- 1119779
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MJM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964015 | INDICARD TEST | Litmus Concepts, Inc. | 1997-06-19 |
Legacy Summary#
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FDA Review#
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