ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT— 510(k) K982121
Substantially EquivalentTrace Scientific , Ltd.
FDA 510(k) clearance K982121 for ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT, Substantially Equivalent on 1998-09-17. Applicant: Trace Scientific , Ltd.. Device class: 2.
Clearance details
- Applicant
- Trace Scientific , Ltd.
- Product code
- Code DBM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5090
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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More clearances from Trace Scientific , Ltd.
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