AUTOSTAT(TM) ANTI-DSNA— 510(k) K913342
Substantially EquivalentCogent Diagnotics , Ltd.
FDA 510(k) clearance K913342 for AUTOSTAT(TM) ANTI-DSNA, Substantially Equivalent on 1992-05-01. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Cogent Diagnotics , Ltd.
- Product code
- Code LKJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dunblane, Fk15 9ep, GB
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