AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT— 510(k) K850739
Substantially EquivalentSyva Co.
FDA 510(k) clearance K850739 for AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT, Substantially Equivalent on 1985-03-11. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code GQL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.