CMV-VUE(TM) CMV ANTIGEN DETECTION KIT— 510(k) K921616
Substantially Equivalent for Some IndicationsIncstar Corp.
FDA 510(k) clearance K921616 for CMV-VUE(TM) CMV ANTIGEN DETECTION KIT, Substantially Equivalent for Some Indications on 1992-08-11. Applicant: Incstar Corp.. Device class: 2.
Clearance details
- Applicant
- Incstar Corp.
- Product code
- Code LIN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
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