510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760673Substantially Equivalent

Rapi/tex-Lgm Kit

Hoechst-Roussel Pharmaceuticals, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760673 is the FDA 510(k) clearance record for RAPI/TEX-LGM KIT, a class II device, cleared for Hoechst-Roussel Pharmaceuticals, Inc. on under FDA product code DFT (Igm, Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Hoechst-Roussel Pharmaceuticals, Inc. As of , FDA records show no recalls naming K760673.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DFT Igm, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Hoechst-Roussel Pharmaceuticals, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DFT

Trailing 12 months

FDA records hold no clearances under product code DFT in the trailing twelve months.

FDA records show no clearances under product code DFT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DFT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260