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FDA 510(k)

FIBRO-TEC TEST KIT

K-Number: K791358 · 1979-09-04

ApplicantCalbiochem-Behring Corp.
Decision Date1979-09-04
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRO-TEC TEST KIT 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 1979-09-04 under 510(k) number K791358. The device is classified under product code GHH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRO-TEC TEST KIT?

FIBRO-TEC TEST KIT is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K791358.

When did FIBRO-TEC TEST KIT receive FDA 510(k) clearance?

FIBRO-TEC TEST KIT received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791358.

Who is the listed applicant for FIBRO-TEC TEST KIT?

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 FIBRO-TEC TEST KIT?

The FDA product code for FIBRO-TEC TEST KIT is GHH.

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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: GHH)

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.

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme LaboratoriesK072288PATHFAST D-DIMERMitsubishi Kagaku IatronK070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOlympus Life & Material Science Europa GmbH (IrishK062203TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K042890TRIAGE D-DIMER TEST, MODEL 98100Biosite IncorporatedK030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.

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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