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FDA 510(k)

MMH PTH RIA KIT

K-Number: K830700 · 1983-04-06

ApplicantDiagnostic Systems
Decision Date1983-04-06
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MMH PTH RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830700. 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 MMH PTH RIA KIT?

MMH PTH RIA KIT is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Diagnostic Systems. The 510(k) number is K830700.

When did MMH PTH RIA KIT receive FDA 510(k) clearance?

MMH PTH RIA KIT received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830700.

Who is the listed applicant for MMH PTH RIA KIT?

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

What is the FDA product code for MMH PTH RIA KIT?

The FDA product code for MMH PTH RIA KIT is CEW.

Other records listing Diagnostic Systems as applicant

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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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