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FDA 510(k)

IN VITRO DIAGNOSTIC REAGENT

K-Number: K772096 · 1977-11-22

ApplicantPcl-Ria, Inc.
Decision Date1977-11-22
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN VITRO DIAGNOSTIC REAGENT 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 1977-11-22 under 510(k) number K772096. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VITRO DIAGNOSTIC REAGENT?

IN VITRO DIAGNOSTIC REAGENT is a medical device that received FDA 510(k) clearance on 1977-11-22. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K772096.

When did IN VITRO DIAGNOSTIC REAGENT receive FDA 510(k) clearance?

IN VITRO DIAGNOSTIC REAGENT received FDA 510(k) clearance on 1977-11-22, under 510(k) number K772096.

Who is the listed applicant for IN VITRO DIAGNOSTIC REAGENT?

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 IN VITRO DIAGNOSTIC REAGENT?

The FDA product code for IN VITRO DIAGNOSTIC REAGENT is CDX.

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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: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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