GLUCOSE-HK REAGENT— 510(k) K873835

Substantially Equivalent

Intersect Systems, Inc.

FDA 510(k) clearance K873835 for GLUCOSE-HK REAGENT, Substantially Equivalent on 1987-11-24. Applicant: Intersect Systems, Inc.. Device class: 2.

Clearance details

Applicant
Intersect Systems, Inc.
Product code
Code CFR
Device class
Class 2
Regulation
21 CFR 862.1345
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Longview, WA, US
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