ALP (OPT) REAGENT— 510(k) K862905

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K862905 for ALP (OPT) REAGENT, Substantially Equivalent on 1986-08-29. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code CJE
Advisory panel: Clinical Chemistry
Date received: 1986-07-31
Decision date: 1986-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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