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FDA 510(k)

C-TERMINAL PTH RIA KIT

K-Number: K853784 · 1985-10-04

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1985-10-04
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

C-TERMINAL PTH RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853784. 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 C-TERMINAL PTH RIA KIT?

C-TERMINAL PTH RIA KIT is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K853784.

When did C-TERMINAL PTH RIA KIT receive FDA 510(k) clearance?

C-TERMINAL PTH RIA KIT received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853784.

Who is the listed applicant for C-TERMINAL PTH RIA KIT?

The FDA 510(k) record lists Diagnostic Systems Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-TERMINAL PTH RIA KIT?

The FDA product code for C-TERMINAL PTH RIA KIT 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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