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FDA 510(k)

IMMUNOGLOBULIN E TEST KIT

K-Number: K800995 · 1980-05-14

ApplicantCalbiochem-Behring Corp.
Decision Date1980-05-14
Product CodeDGO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGLOBULIN E 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 1980-05-14 under 510(k) number K800995. The device is classified under product code DGO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOGLOBULIN E TEST KIT?

IMMUNOGLOBULIN E TEST KIT is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K800995.

When did IMMUNOGLOBULIN E TEST KIT receive FDA 510(k) clearance?

IMMUNOGLOBULIN E TEST KIT received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800995.

Who is the listed applicant for IMMUNOGLOBULIN E 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 IMMUNOGLOBULIN E TEST KIT?

The FDA product code for IMMUNOGLOBULIN E TEST KIT is DGO.

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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: DGO)

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.

K943194IMMULITE(R) ALLERGY FOOD PANEL FP5EDiagnostic Products Corp.K920087IGE EIA TEST KITThe Binding Site, Ltd.K911511ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIEDDiagnostic Products Corp.K894039QUIDEL TOTAL IGE TEST QUANTITATIVE VERSIONQuidel Corp.K893125BECKMAN EPSILON(TM) IGE REAGENT KITBeckman Instruments, Inc.K872801ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5Diagnostic Products 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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