REP SPE VIS-60/40 KIT— 510(k) K973316

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K973316 for REP SPE VIS-60/40 KIT, Substantially Equivalent on 1997-10-01. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CEF
Advisory panel: Clinical Chemistry
Date received: 1997-09-03
Decision date: 1997-10-01
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.