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FDA 510(k)

COAT-A-COUNT INTACT PTH IRMA

K-Number: K930008 · 1993-06-15

ApplicantDiagnostic Products Corp.
Decision Date1993-06-15
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT INTACT PTH IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1993-06-15 under 510(k) number K930008. 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 COAT-A-COUNT INTACT PTH IRMA?

COAT-A-COUNT INTACT PTH IRMA is a medical device that received FDA 510(k) clearance on 1993-06-15. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K930008.

When did COAT-A-COUNT INTACT PTH IRMA receive FDA 510(k) clearance?

COAT-A-COUNT INTACT PTH IRMA received FDA 510(k) clearance on 1993-06-15, under 510(k) number K930008.

Who is the listed applicant for COAT-A-COUNT INTACT PTH IRMA?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COAT-A-COUNT INTACT PTH IRMA?

The FDA product code for COAT-A-COUNT INTACT 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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