FDA 510(k)

RAPI/TEX-LGM KIT

K-Number: K760673 · 1976-12-19

ApplicantHoechst-Roussel Pharmaceuticals, Inc.

Decision Date1976-12-19

Product CodeDFT

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

RAPI/TEX-LGM KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hoechst-Roussel Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1976-12-19 under 510(k) number K760673. The device is classified under product code DFT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPI/TEX-LGM KIT?

RAPI/TEX-LGM KIT is a medical device that received FDA 510(k) clearance on 1976-12-19. The listed applicant is Hoechst-Roussel Pharmaceuticals, Inc.. The 510(k) number is K760673.

When did RAPI/TEX-LGM KIT receive FDA 510(k) clearance?

RAPI/TEX-LGM KIT received FDA 510(k) clearance on 1976-12-19, under 510(k) number K760673.

Who is the listed applicant for RAPI/TEX-LGM KIT?

The FDA 510(k) record lists Hoechst-Roussel Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPI/TEX-LGM KIT?

The FDA product code for RAPI/TEX-LGM KIT is DFT.

Related Devices (Code: DFT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983132IGMAbbott Laboratories K962201QUANTEX IGMInstrumentation Laboratory CO K955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems Group K901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODIsolab, Inc.K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.