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FDA 510(k)

DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT

K-Number: K810966 · 1981-04-21

ApplicantE. R. Squibb & Sons, Inc.
Decision Date1981-04-21
Product CodeDNL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is E. R. Squibb & Sons, Inc.. It received FDA 510(k) clearance on 1981-04-21 under 510(k) number K810966. 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 DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT?

DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1981-04-21. The listed applicant is E. R. Squibb & Sons, Inc.. The 510(k) number is K810966.

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

DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1981-04-21, under 510(k) number K810966.

Who is the listed applicant for DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists E. R. Squibb & Sons, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT?

The FDA product code for DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT is DNL.

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Other records listing E. R. Squibb & Sons, 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.

K821494RIA STAT 16K820616ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAYK820341CORTISOL-SQUIBB RADIOIMMUNOASSAY KITK820340T3 UPTAKE-SQUIBB DIAGNOSTIC KITK811240SUR-FIT LOOP OSTOMY O.R. SETK811239SUR-FIT DISPOSABLE CONVEX INSERT

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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.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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