ORGENTEC MICRO-ALBUMIN EIA ASSAY— 510(k) K970932
Substantially EquivalentAmerican Laboratory Products Co., Ltd.
FDA 510(k) clearance K970932 for ORGENTEC MICRO-ALBUMIN EIA ASSAY, Substantially Equivalent on 1997-04-08. Applicant: American Laboratory Products Co., Ltd..
Clearance details
- Applicant
- American Laboratory Products Co., Ltd.
- Product code
- Code JIR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, NH, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.