THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II— 510(k) K911170

Substantially Equivalent

Analytical Control Systems, Inc.

FDA 510(k) clearance K911170 for THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II, Substantially Equivalent on 1991-05-01. Applicant: Analytical Control Systems, Inc.. Device class: 1.

Clearance details

Applicant
Analytical Control Systems, Inc.
Product code
Code JIY
Device class
Class 1
Regulation
21 CFR 862.1410
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fishers, IN, US
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