INFLUENZA MAB TEST/INFLUENZA B TEST— 510(k) K913214
Substantially EquivalentGull Laboratories, Inc.
FDA 510(k) clearance K913214 for INFLUENZA MAB TEST/INFLUENZA B TEST, Substantially Equivalent on 1991-12-13. Applicant: Gull Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Gull Laboratories, Inc.
- Product code
- Code GNW
- Device class
- Class 1
- Regulation
- 21 CFR 866.3330
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
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