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FDA 510(k)

IMMUNOGLOBULIN M REAGENT SYSTEM

K-Number: K800167 · 1980-02-05

ApplicantCalbiochem-Behring Corp.
Decision Date1980-02-05
Product CodeDFT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGLOBULIN M REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K800167. 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 IMMUNOGLOBULIN M REAGENT SYSTEM?

IMMUNOGLOBULIN M REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K800167.

When did IMMUNOGLOBULIN M REAGENT SYSTEM receive FDA 510(k) clearance?

IMMUNOGLOBULIN M REAGENT SYSTEM received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800167.

Who is the listed applicant for IMMUNOGLOBULIN M REAGENT SYSTEM?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOGLOBULIN M REAGENT SYSTEM?

The FDA product code for IMMUNOGLOBULIN M REAGENT SYSTEM is DFT.

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Other records listing Calbiochem-Behring Corp. as applicant

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.

K831811REVOLUTION RADIAL IMMUNODIFFUSION PLATEK831036ENA TEST KIT SM & RNP AUTO ANTIBODYK830214AFT SYSTEM IIIK820812CREATINE KINASE-MB KITK813493ENZYGNOST TM RUBELLA IGMK820088AFT SYSTEM PROFICIENCY TESTING PROGRAM

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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 LaboratoriesK962201QUANTEX IGMInstrumentation Laboratory COK955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems GroupK901453QUIK-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.

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