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FDA 510(k)

QUANTICLONE IGE RADIOIMMUNASSAY

K-Number: K852268 · 1985-07-10

ApplicantKallestad Laboratories, Inc.
Decision Date1985-07-10
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTICLONE IGE RADIOIMMUNASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1985-07-10 under 510(k) number K852268. 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 QUANTICLONE IGE RADIOIMMUNASSAY?

QUANTICLONE IGE RADIOIMMUNASSAY is a medical device that received FDA 510(k) clearance on 1985-07-10. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K852268.

When did QUANTICLONE IGE RADIOIMMUNASSAY receive FDA 510(k) clearance?

QUANTICLONE IGE RADIOIMMUNASSAY received FDA 510(k) clearance on 1985-07-10, under 510(k) number K852268.

Who is the listed applicant for QUANTICLONE IGE RADIOIMMUNASSAY?

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

What is the FDA product code for QUANTICLONE IGE RADIOIMMUNASSAY?

The FDA product code for QUANTICLONE IGE RADIOIMMUNASSAY is DGC.

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Other records listing Kallestad Laboratories, 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

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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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