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FDA 510(k)

PTH MR

K-Number: K831470 · 1983-06-22

ApplicantRamco Laboratories, Inc.
Decision Date1983-06-22
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PTH MR is the device name listed in this FDA 510(k) record. The listed applicant is Ramco Laboratories, Inc.. It received FDA 510(k) clearance on 1983-06-22 under 510(k) number K831470. 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 PTH MR?

PTH MR is a medical device that received FDA 510(k) clearance on 1983-06-22. The listed applicant is Ramco Laboratories, Inc.. The 510(k) number is K831470.

When did PTH MR receive FDA 510(k) clearance?

PTH MR received FDA 510(k) clearance on 1983-06-22, under 510(k) number K831470.

Who is the listed applicant for PTH MR?

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

What is the FDA product code for PTH MR?

The FDA product code for PTH MR is CEW.

Other records listing Ramco Laboratories, 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.

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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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