ADP REAGENT, MODIFIED— 510(k) K952252

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K952252 for ADP REAGENT, MODIFIED, Substantially Equivalent on 1995-09-08. Applicant: Helena Laboratories. Device class: 2.

Clearance details

Applicant: Helena Laboratories
Product code: Code GHR
Device class: Class 2
Regulation: 21 CFR 864.5700
Advisory panel: Hematology
Date received: 1995-05-15
Decision date: 1995-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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