GBACT + KIT— 510(k) K984141

Substantially Equivalent

Sienco, Inc.

FDA 510(k) clearance K984141 for GBACT + KIT, Substantially Equivalent on 1999-05-28. Applicant: Sienco, Inc.. Device class: 2.

Clearance details

Applicant: Sienco, Inc.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1998-11-18
Decision date: 1999-05-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Wheatridge, CO, US

Download summary PDF View on FDA.gov ↗

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