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FDA 510(k)

TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY

K-Number: K823507 · 1982-12-28

ApplicantHybritech, Inc.
Decision Date1982-12-28
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823507. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY?

TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Hybritech, Inc.. The 510(k) number is K823507.

When did TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY receive FDA 510(k) clearance?

TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823507.

Who is the listed applicant for TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY?

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

What is the FDA product code for TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY?

The FDA product code for TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY is DGC.

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Other records listing Hybritech, Inc. 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.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

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Related Devices (Code: DGC)

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.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, 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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