IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)— 510(k) K901975

Substantially Equivalent

Savyon Diagnostics , Ltd.

FDA 510(k) clearance K901975 for IPAZYME(TM) CHLAMYDIA TRUE IGM(TM), Substantially Equivalent on 1991-03-08. Applicant: Savyon Diagnostics , Ltd..

Clearance details

Applicant: Savyon Diagnostics , Ltd.
Product code: Code LKH
Advisory panel: Microbiology
Date received: 1990-05-01
Decision date: 1991-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashdod, IL

Download summary PDF View on FDA.gov ↗

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