ORGENTEC ANTI-SS-A(RO) ELISA— 510(k) K962054

Substantially Equivalent

American Laboratory Products Co., Ltd.

FDA 510(k) clearance K962054 for ORGENTEC ANTI-SS-A(RO) ELISA, Substantially Equivalent on 1996-11-15. Applicant: American Laboratory Products Co., Ltd..

Clearance details

Applicant
American Laboratory Products Co., Ltd.
Product code
Code LJM
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Windham, NH, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.