AUTOSTAT II ANTI-SM/RNP ELISA— 510(k) K990624
Substantially EquivalentCogent Diagnotics , Ltd.
FDA 510(k) clearance K990624 for AUTOSTAT II ANTI-SM/RNP ELISA, Substantially Equivalent on 1999-04-28. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Cogent Diagnotics , Ltd.
- Product code
- Code LKO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Midlothian, Scotland, GB
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More clearances from Cogent Diagnotics , Ltd.
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