RAPI/TEX-LGM KIT— 510(k) K760673

Name: FDA 510(k) clearance K760673
Creator: U.S. Food and Drug Administration
Published: 1976-12-19

Substantially Equivalent

Hoechst-Roussel Pharmaceuticals, Inc.

FDA 510(k) clearance K760673 for RAPI/TEX-LGM KIT, Substantially Equivalent on 1976-12-19. Applicant: Hoechst-Roussel Pharmaceuticals, Inc.. Device class: 2.

Clearance details

Applicant: Hoechst-Roussel Pharmaceuticals, Inc.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1976-09-20
Decision date: 1976-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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