ROCHE LACTATE ANALYZER 640— 510(k) K790421

Name: FDA 510(k) clearance K790421
Creator: U.S. Food and Drug Administration
Published: 1979-05-15

Substantially Equivalent

Roche Medical Electronics, Inc.

FDA 510(k) clearance K790421 for ROCHE LACTATE ANALYZER 640, Substantially Equivalent on 1979-05-15. Applicant: Roche Medical Electronics, Inc.. Device class: 1.

Clearance details

Applicant: Roche Medical Electronics, Inc.
Product code: Code KHP
Device class: Class 1
Regulation: 21 CFR 862.1450
Advisory panel: Clinical Chemistry
Date received: 1979-02-28
Decision date: 1979-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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