ORGENTEC ANTI-PR3 (C-ANCA) ELISA— 510(k) K974702
Substantially EquivalentAmerican Laboratory Products Co., Ltd.
FDA 510(k) clearance K974702 for ORGENTEC ANTI-PR3 (C-ANCA) ELISA, Substantially Equivalent on 1998-02-17. Applicant: American Laboratory Products Co., Ltd..
Clearance details
- Applicant
- American Laboratory Products Co., Ltd.
- Product code
- Code MOB
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, NH, US
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