AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA— 510(k) K043433
Substantially EquivalentHycor Biomedical , Ltd.
FDA 510(k) clearance K043433 for AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA, Substantially Equivalent on 2005-03-07. Applicant: Hycor Biomedical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Hycor Biomedical , Ltd.
- Product code
- Code MVM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Penicuik, Midlothian, GB
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