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FDA 510(k)

DIGOXIN (RIA) KIT

K-Number: K811212 · 1981-05-21

ApplicantImmuno Assay Corp.
Decision Date1981-05-21
Product CodeDNL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN (RIA) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Assay Corp.. It received FDA 510(k) clearance on 1981-05-21 under 510(k) number K811212. 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 (RIA) KIT?

DIGOXIN (RIA) KIT is a medical device that received FDA 510(k) clearance on 1981-05-21. The listed applicant is Immuno Assay Corp.. The 510(k) number is K811212.

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

DIGOXIN (RIA) KIT received FDA 510(k) clearance on 1981-05-21, under 510(k) number K811212.

Who is the listed applicant for DIGOXIN (RIA) KIT?

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

What is the FDA product code for DIGOXIN (RIA) KIT?

The FDA product code for DIGOXIN (RIA) KIT is DNL.

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Other records listing Immuno Assay 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.

K833842RIA COAT DIGOXINK833745RIACOAT T-4K820089TSH (RIA) KITK820074CORTISOL (RIA) KITK811954COMBO-FER IRON DIAGNOSTICK811725TBG DIAGNOSTIC KIT

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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.K810966DIAGOXIN SQUIBB RADIOIMMUNOASSAY KITE. R. Squibb & Sons, Inc.K802841DIGOXIN RADIOIMMUNOASSAY KITAmerican Diagnostic Corp.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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