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FDA 510(k)

DIG RADIOIMMUNOASSAY TEST SYSTEM

K-Number: K852343 · 1985-07-09

ApplicantM Nobird, Inc.
Decision Date1985-07-09
Product CodeDNL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIG RADIOIMMUNOASSAY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is M Nobird, Inc.. It received FDA 510(k) clearance on 1985-07-09 under 510(k) number K852343. 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 DIG RADIOIMMUNOASSAY TEST SYSTEM?

DIG RADIOIMMUNOASSAY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is M Nobird, Inc.. The 510(k) number is K852343.

When did DIG RADIOIMMUNOASSAY TEST SYSTEM receive FDA 510(k) clearance?

DIG RADIOIMMUNOASSAY TEST SYSTEM received FDA 510(k) clearance on 1985-07-09, under 510(k) number K852343.

Who is the listed applicant for DIG RADIOIMMUNOASSAY TEST SYSTEM?

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

What is the FDA product code for DIG RADIOIMMUNOASSAY TEST SYSTEM?

The FDA product code for DIG RADIOIMMUNOASSAY TEST SYSTEM is DNL.

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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.

K852291TIPSEP DIGOXIN RIANuclear Diagnostics, Inc.K811212DIGOXIN (RIA) KITImmuno Assay Corp.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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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