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FDA 510(k)

ELISA FOR TOTAL IGE

K-Number: K843710 · 1984-10-22

ApplicantScientific Research
Decision Date1984-10-22
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELISA FOR TOTAL IGE is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Research. It received FDA 510(k) clearance on 1984-10-22 under 510(k) number K843710. 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 ELISA FOR TOTAL IGE?

ELISA FOR TOTAL IGE is a medical device that received FDA 510(k) clearance on 1984-10-22. The listed applicant is Scientific Research. The 510(k) number is K843710.

When did ELISA FOR TOTAL IGE receive FDA 510(k) clearance?

ELISA FOR TOTAL IGE received FDA 510(k) clearance on 1984-10-22, under 510(k) number K843710.

Who is the listed applicant for ELISA FOR TOTAL IGE?

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

What is the FDA product code for ELISA FOR TOTAL IGE?

The FDA product code for ELISA FOR TOTAL IGE is DGC.

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Other records listing Scientific Research 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.

K912420ORTHOFIX UNREAMED TIBIAL NAIL SYSTEMK843077ELISA FOR HERPES SIMPLEX VIRUSK842887HERPES VIRUS AGGLUTINATION TESTK843369AGGLUTINATION TEST FOR TOTAL IGE

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

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

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