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FDA 510(k)

GAMMADAB[125]EGE RADIOIMMUNOASSAY IT

K-Number: K821092 · 1982-06-22

ApplicantClinical Assays, Inc.
Decision Date1982-06-22
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GAMMADAB[125]EGE RADIOIMMUNOASSAY IT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1982-06-22 under 510(k) number K821092. 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 GAMMADAB[125]EGE RADIOIMMUNOASSAY IT?

GAMMADAB[125]EGE RADIOIMMUNOASSAY IT is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K821092.

When did GAMMADAB[125]EGE RADIOIMMUNOASSAY IT receive FDA 510(k) clearance?

GAMMADAB[125]EGE RADIOIMMUNOASSAY IT received FDA 510(k) clearance on 1982-06-22, under 510(k) number K821092.

Who is the listed applicant for GAMMADAB[125]EGE RADIOIMMUNOASSAY IT?

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

What is the FDA product code for GAMMADAB[125]EGE RADIOIMMUNOASSAY IT?

The FDA product code for GAMMADAB[125]EGE RADIOIMMUNOASSAY IT is DGC.

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Other records listing Clinical Assays, 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.

K832711VITAMIN B12 FOLATE CA-1515-125K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832712FOLATE RADIOASSAY KIT CA-1562-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KIT

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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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