MONO-PHILE— 510(k) K881247

Substantially Equivalent

Bio Diagnostic Systems, Inc.

FDA 510(k) clearance K881247 for MONO-PHILE, Substantially Equivalent on 1988-04-07. Applicant: Bio Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Bio Diagnostic Systems, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1988-03-23
Decision date: 1988-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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