KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT— 510(k) K884485

Name: FDA 510(k) clearance K884485
Creator: U.S. Food and Drug Administration
Published: 1988-12-28

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K884485 for KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT, Substantially Equivalent on 1988-12-28. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1988-10-25
Decision date: 1988-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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