ORGENTEC ANTI-RNP/SM ELISA— 510(k) K962057
Substantially EquivalentAmerican Laboratory Products Co., Ltd.
FDA 510(k) clearance K962057 for ORGENTEC ANTI-RNP/SM ELISA, Substantially Equivalent on 1996-11-18. Applicant: American Laboratory Products Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- American Laboratory Products Co., Ltd.
- Product code
- Code LJM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, NH, US
Recent devices under product code LJM
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