OVU STICK SELF-TEST -MODIFICATION— 510(k) K850480
Substantially EquivalentMonoclonal Antibodies, Inc.
FDA 510(k) clearance K850480 for OVU STICK SELF-TEST -MODIFICATION, Substantially Equivalent on 1985-03-05. Applicant: Monoclonal Antibodies, Inc.. Device class: 1.
Clearance details
- Applicant
- Monoclonal Antibodies, Inc.
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code CEP
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