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FDA 510(k)

RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E

K-Number: K830357 · 1983-03-17

ApplicantClinetics Corp.
Decision Date1983-03-17
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E is the device name listed in this FDA 510(k) record. The listed applicant is Clinetics Corp.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K830357. 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 RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E?

RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Clinetics Corp.. The 510(k) number is K830357.

When did RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E receive FDA 510(k) clearance?

RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830357.

Who is the listed applicant for RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E?

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

What is the FDA product code for RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E?

The FDA product code for RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E is DGC.

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Other records listing Clinetics Corp. 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.

K862180MODIFIED COTROPIN RADIOIMMUNOASSAY KITK844066COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSHK841580TSH RECEPTOR ANTIBODY KIT 125I TSHK833934ADRENOCORTICOTROPIC HORMONE TESTK823380125-I LH RADIOIMMUNOASSAY KITK823379125-I FSH RADIOIMMUNOASSAY 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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