AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA— 510(k) K990796
Substantially EquivalentCogent Diagnotics , Ltd.
FDA 510(k) clearance K990796 for AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA, Substantially Equivalent on 1999-04-28. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Cogent Diagnotics , Ltd.
- Product code
- Code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Midlothian, Scotland, GB
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