DOCUMENT TDM ULTRA ASSAYED CONTROL— 510(k) K960244

Substantially Equivalent

Casco Standards

FDA 510(k) clearance K960244 for DOCUMENT TDM ULTRA ASSAYED CONTROL, Substantially Equivalent on 1996-03-22. Applicant: Casco Standards. Device class: 1.

Clearance details

Applicant
Casco Standards
Product code
Code DIF
Device class
Class 1
Regulation
21 CFR 862.3280
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yarmouth, ME, US
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