ROCHE REAGENT FOR INORGANIC PHOSPHORUS— 510(k) K883962

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K883962 for ROCHE REAGENT FOR INORGANIC PHOSPHORUS, Substantially Equivalent on 1988-11-29. Applicant: Roche Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant
Roche Diagnostic Systems, Inc.
Product code
Code CEO
Device class
Class 1
Regulation
21 CFR 862.1580
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montclair, NJ, US
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