REMEL STAPH LATEX KIT— 510(k) K964315
Substantially EquivalentRemel, L.P.
FDA 510(k) clearance K964315 for REMEL STAPH LATEX KIT, Substantially Equivalent on 1997-02-07. Applicant: Remel, L.P.. Device class: 1.
Clearance details
- Applicant
- Remel, L.P.
- Product code
- Code JWX
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Augusta, GA, US
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