STRATUS CS MYOGLOBIN (MYO) TESTPAK— 510(k) K981102

Name: FDA 510(k) clearance K981102
Creator: U.S. Food and Drug Administration
Published: 1998-04-27

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K981102 for STRATUS CS MYOGLOBIN (MYO) TESTPAK, Substantially Equivalent on 1998-04-27. Applicant: Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code DDR
Device class: Class 2
Regulation: 21 CFR 866.5680
Advisory panel: Immunology
Date received: 1998-03-26
Decision date: 1998-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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