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FDA 510(k)

RABBIT ANTIBODY TO DIGOXIN

K-Number: K780316 · 1978-03-17

ApplicantPcl-Ria, Inc.
Decision Date1978-03-17
Product CodeDKA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RABBIT ANTIBODY TO DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Pcl-Ria, Inc.. It received FDA 510(k) clearance on 1978-03-17 under 510(k) number K780316. The device is classified under product code DKA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RABBIT ANTIBODY TO DIGOXIN?

RABBIT ANTIBODY TO DIGOXIN is a medical device that received FDA 510(k) clearance on 1978-03-17. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K780316.

When did RABBIT ANTIBODY TO DIGOXIN receive FDA 510(k) clearance?

RABBIT ANTIBODY TO DIGOXIN received FDA 510(k) clearance on 1978-03-17, under 510(k) number K780316.

Who is the listed applicant for RABBIT ANTIBODY TO DIGOXIN?

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

What is the FDA product code for RABBIT ANTIBODY TO DIGOXIN?

The FDA product code for RABBIT ANTIBODY TO DIGOXIN is DKA.

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Other records listing Pcl-Ria, 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.

K830526B-GCG SYSTEM BY RIAK822935THYROID STIMULATING HORMONEK823014DIGOXIN KITK822612T3 UPTAKE KITSK820886THYROXINE T4 KITK820358FOLLICLE STIMULATING HORMONE KIT

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Related Devices (Code: DKA)

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.

K934003STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAYBaxter Diagnostics, Inc.K780498CBR-DIGOXIN ANTISERUMClinical Bioresearch

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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