MONO-PLUS(TM)— 510(k) K883004

Substantially Equivalent

Wampole Laboratories

FDA 510(k) clearance K883004 for MONO-PLUS(TM), Substantially Equivalent on 1988-08-04. Applicant: Wampole Laboratories. Device class: 2.

Clearance details

Applicant: Wampole Laboratories
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1988-07-18
Decision date: 1988-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.