STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW— 510(k) K060968

Name: FDA 510(k) clearance K060968
Creator: U.S. Food and Drug Administration
Published: 2007-05-15

Substantially Equivalent

Wortham Laboratories, Inc.

FDA 510(k) clearance K060968 for STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW, Substantially Equivalent on 2007-05-15. Applicant: Wortham Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Wortham Laboratories, Inc.
Product code: Code GIZ
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2006-04-07
Decision date: 2007-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chattanooga, TN, US

Download summary PDF View on FDA.gov ↗

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