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FDA 510(k)

PTH-MM II 125I RADIOIMMUNOASSAY (RIA)

K-Number: K901711 · 1990-07-16

ApplicantIncstar Corp.
Decision Date1990-07-16
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PTH-MM II 125I RADIOIMMUNOASSAY (RIA) is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1990-07-16 under 510(k) number K901711. 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-MM II 125I RADIOIMMUNOASSAY (RIA)?

PTH-MM II 125I RADIOIMMUNOASSAY (RIA) is a medical device that received FDA 510(k) clearance on 1990-07-16. The listed applicant is Incstar Corp.. The 510(k) number is K901711.

When did PTH-MM II 125I RADIOIMMUNOASSAY (RIA) receive FDA 510(k) clearance?

PTH-MM II 125I RADIOIMMUNOASSAY (RIA) received FDA 510(k) clearance on 1990-07-16, under 510(k) number K901711.

Who is the listed applicant for PTH-MM II 125I RADIOIMMUNOASSAY (RIA)?

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

What is the FDA product code for PTH-MM II 125I RADIOIMMUNOASSAY (RIA)?

The FDA product code for PTH-MM II 125I RADIOIMMUNOASSAY (RIA) 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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