PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2— 510(k) K994045

Name: FDA 510(k) clearance K994045
Creator: U.S. Food and Drug Administration
Published: 1999-12-21

Substantially Equivalent

Primus Corp.

FDA 510(k) clearance K994045 for PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2, Substantially Equivalent on 1999-12-21. Applicant: Primus Corp.. Device class: 2.

Clearance details

Applicant: Primus Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1999-11-29
Decision date: 1999-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.