ANA HEP-2 FLUORO-KIT— 510(k) K822397

Substantially Equivalent

Clinical Sciences, Inc.

FDA 510(k) clearance K822397 for ANA HEP-2 FLUORO-KIT, Substantially Equivalent on 1982-09-21. Applicant: Clinical Sciences, Inc.. Device class: 2.

Clearance details

Applicant
Clinical Sciences, Inc.
Product code
Code DHN
Device class
Class 2
Regulation
21 CFR 866.5100
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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