K922024

Substantially Equivalent

REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175

Applicant: Helena Laboratories
Product code: CEF
Advisory panel: Clinical Chemistry
Date received: 1992-05-01
Decision date: 1992-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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