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FDA 510(k)

DIGOXIN RADIOIMMUNOASSAY KIT

K-Number: K802841 · 1980-12-18

ApplicantAmerican Diagnostic Corp.
Decision Date1980-12-18
Product CodeDNL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K802841. The device is classified under product code DNL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGOXIN RADIOIMMUNOASSAY KIT?

DIGOXIN RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is American Diagnostic Corp.. The 510(k) number is K802841.

When did DIGOXIN RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

DIGOXIN RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802841.

Who is the listed applicant for DIGOXIN RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for DIGOXIN RADIOIMMUNOASSAY KIT?

The FDA product code for DIGOXIN RADIOIMMUNOASSAY KIT is DNL.

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Other records listing American Diagnostic 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.

K162589Adscope 658 Electronic StethoscopeK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSK060321ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BKK012304ADC 656 ELECTRONIC STETHOSCOPEK962655ANEROID AND MERCURIAL SPHYGMOMANOMETERSK940686ELECTRONIC THERMOMETERS

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Related Devices (Code: DNL)

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.

K852343DIG RADIOIMMUNOASSAY TEST SYSTEMM Nobird, Inc.K852291TIPSEP DIGOXIN RIANuclear Diagnostics, Inc.K811212DIGOXIN (RIA) KITImmuno Assay Corp.K810966DIAGOXIN SQUIBB RADIOIMMUNOASSAY KITE. R. Squibb & Sons, Inc.K781834TEST SET, 125 I-DIGOXINWien Laboratories, Inc.K781495RIANEN ASSAY SYSTEM, 125I KITNew England Nuclear

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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