MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5— 510(k) K991277

Name: FDA 510(k) clearance K991277
Creator: U.S. Food and Drug Administration
Published: 1999-04-27

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K991277 for MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5, Substantially Equivalent on 1999-04-27. Applicant: Diagnostic Products Corp.. Device class: 2.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code DDR
Device class: Class 2
Regulation: 21 CFR 866.5680
Advisory panel: Immunology
Date received: 1999-04-14
Decision date: 1999-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Los Angeles, CA, 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.