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FDA 510(k)

SECOND ANTIBODY

K-Number: K781070 · 1978-08-10

ApplicantPcl-Ria, Inc.
Decision Date1978-08-10
Product CodeKTS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SECOND ANTIBODY 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 1978-08-10 under 510(k) number K781070. The device is classified under product code KTS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECOND ANTIBODY?

SECOND ANTIBODY is a medical device that received FDA 510(k) clearance on 1978-08-10. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K781070.

When did SECOND ANTIBODY receive FDA 510(k) clearance?

SECOND ANTIBODY received FDA 510(k) clearance on 1978-08-10, under 510(k) number K781070.

Who is the listed applicant for SECOND ANTIBODY?

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 SECOND ANTIBODY?

The FDA product code for SECOND ANTIBODY is KTS.

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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: KTS)

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.

K813508SAC-CELBurroughs Wellcome Co.K792636CENTRIA RADIOIMMUNOASSAY SEPARATIONUnion Carbide Corp.K792637CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT)Union Carbide Corp.

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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