THROMBO-SCREEN AT-111 KIT— 510(k) K770394

Name: FDA 510(k) clearance K770394
Creator: U.S. Food and Drug Administration
Published: 1977-03-30

Substantially Equivalent

Bay Area Hema. Onco. Clinic. & Res. L

FDA 510(k) clearance K770394 for THROMBO-SCREEN AT-111 KIT, Substantially Equivalent on 1977-03-30. Applicant: Bay Area Hema. Onco. Clinic. & Res. L. Device class: 2.

Clearance details

Applicant: Bay Area Hema. Onco. Clinic. & Res. L
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1977-02-28
Decision date: 1977-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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