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FDA 510(k)

COTUBE PTH IRMA

K-Number: K921949 · 1992-09-02

ApplicantBio-Rad
Decision Date1992-09-02
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COTUBE PTH IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1992-09-02 under 510(k) number K921949. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COTUBE PTH IRMA?

COTUBE PTH IRMA is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Bio-Rad. The 510(k) number is K921949.

When did COTUBE PTH IRMA receive FDA 510(k) clearance?

COTUBE PTH IRMA received FDA 510(k) clearance on 1992-09-02, under 510(k) number K921949.

Who is the listed applicant for COTUBE PTH IRMA?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COTUBE PTH IRMA?

The FDA product code for COTUBE PTH IRMA is CEW.

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Related Devices (Code: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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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