ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL— 510(k) K991498

Substantially Equivalent

Neometrics, Inc.

FDA 510(k) clearance K991498 for ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL, Substantially Equivalent on 1999-06-16. Applicant: Neometrics, Inc.. Device class: 1.

Clearance details

Applicant
Neometrics, Inc.
Product code
Code JIA
Device class
Class 1
Regulation
21 CFR 862.1310
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
E. Northport, NY, US
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