IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5— 510(k) K991796

Name: FDA 510(k) clearance K991796
Creator: U.S. Food and Drug Administration
Published: 1999-06-09

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K991796 for IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5, Substantially Equivalent on 1999-06-09. 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: 1999-05-26
Decision date: 1999-06-09
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.