MAX-ACT— 510(k) K983649

Substantially Equivalent

Array Medical, Inc.

FDA 510(k) clearance K983649 for MAX-ACT, Substantially Equivalent on 1998-12-11. Applicant: Array Medical, Inc.. Device class: 2.

Clearance details

Applicant: Array Medical, Inc.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1998-10-16
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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