MONOCOL/LEX-IM TEST— 510(k) K972457

Substantially Equivalent

Immunostics Inc.,

FDA 510(k) clearance K972457 for MONOCOL/LEX-IM TEST, Substantially Equivalent on 1997-12-01. Applicant: Immunostics Inc.,. Device class: 2.

Clearance details

Applicant: Immunostics Inc.,
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1997-07-01
Decision date: 1997-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ocean, 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.