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FDA 510(k)

MAST LUMINESCENT ALLERGY SYS

K-Number: K841642 · 1984-06-07

ApplicantMast Immunosystems
Decision Date1984-06-07
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MAST LUMINESCENT ALLERGY SYS is the device name listed in this FDA 510(k) record. The listed applicant is Mast Immunosystems. It received FDA 510(k) clearance on 1984-06-07 under 510(k) number K841642. 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 MAST LUMINESCENT ALLERGY SYS?

MAST LUMINESCENT ALLERGY SYS is a medical device that received FDA 510(k) clearance on 1984-06-07. The listed applicant is Mast Immunosystems. The 510(k) number is K841642.

When did MAST LUMINESCENT ALLERGY SYS receive FDA 510(k) clearance?

MAST LUMINESCENT ALLERGY SYS received FDA 510(k) clearance on 1984-06-07, under 510(k) number K841642.

Who is the listed applicant for MAST LUMINESCENT ALLERGY SYS?

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

What is the FDA product code for MAST LUMINESCENT ALLERGY SYS?

The FDA product code for MAST LUMINESCENT ALLERGY SYS is DGC.

Related Clinical Trials

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.

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Other records listing Mast Immunosystems 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.

K934524MAST CLA ALLERGY SYSTEMK926420MAST CLA ALLERGY SYSTEMK914850CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGEK910292MAST CLA ALLERGY SYSTEMK870966TOTAL IGE MASTICKK843694MAST ALLERGY SYSTEM

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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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