QM300 RHEUMATOID FACTOR ANTIGEN PACK— 510(k) K883536

Substantially Equivalent

Kallestad Diag, A Div. of Erbamont, Inc.

FDA 510(k) clearance K883536 for QM300 RHEUMATOID FACTOR ANTIGEN PACK, Substantially Equivalent on 1988-09-07. Applicant: Kallestad Diag, A Div. of Erbamont, Inc..

Clearance details

Applicant: Kallestad Diag, A Div. of Erbamont, Inc.
Product code: Code DHR
Advisory panel: Immunology
Date received: 1988-08-18
Decision date: 1988-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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