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FDA 510(k)

DIGOXIN STANDARDS IN HUMAN SERUM

K-Number: K780889 · 1978-08-14

ApplicantPcl-Ria, Inc.
Decision Date1978-08-14
Product CodeDMP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN STANDARDS IN HUMAN SERUM 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 1978-08-14 under 510(k) number K780889. The device is classified under product code DMP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGOXIN STANDARDS IN HUMAN SERUM?

DIGOXIN STANDARDS IN HUMAN SERUM is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K780889.

When did DIGOXIN STANDARDS IN HUMAN SERUM receive FDA 510(k) clearance?

DIGOXIN STANDARDS IN HUMAN SERUM received FDA 510(k) clearance on 1978-08-14, under 510(k) number K780889.

Who is the listed applicant for DIGOXIN STANDARDS IN HUMAN SERUM?

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 DIGOXIN STANDARDS IN HUMAN SERUM?

The FDA product code for DIGOXIN STANDARDS IN HUMAN SERUM is DMP.

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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: DMP)

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.

K973973ELECSYS CALLCHECK DIGOXINBoehringer Mannheim Corp.K953393TOX PERFECT A TUBEChimera Research & Chemical, Inc.K770411DIGI TROL TM-RX & DIGI TROL TM-TXNuclear Medical Laboratories, Inc.

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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