ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY— 510(k) K962469
Substantially EquivalentAmerican Laboratory Products Co., Ltd.
FDA 510(k) clearance K962469 for ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY, Substantially Equivalent on 1996-09-09. Applicant: American Laboratory Products Co., Ltd..
Clearance details
- Applicant
- American Laboratory Products Co., Ltd.
- Product code
- Code MID
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, NH, US
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