SERA-TEK MYCOPLASMA ANTIBODY TEST— 510(k) K832132
Substantially EquivalentMiles Laboratories, Inc.
FDA 510(k) clearance K832132 for SERA-TEK MYCOPLASMA ANTIBODY TEST, Substantially Equivalent on 1983-09-20. Applicant: Miles Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Miles Laboratories, Inc.
- Product code
- Code GSB
- Device class
- Class 1
- Regulation
- 21 CFR 866.3375
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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