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FDA 510(k)

GAMMA-BCT INTACT PTH

K-Number: K942369 · 1994-09-20

ApplicantImmunodiagnostic Systems , Ltd.
Decision Date1994-09-20
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA-BCT INTACT PTH is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K942369. 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 GAMMA-BCT INTACT PTH?

GAMMA-BCT INTACT PTH is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K942369.

When did GAMMA-BCT INTACT PTH receive FDA 510(k) clearance?

GAMMA-BCT INTACT PTH received FDA 510(k) clearance on 1994-09-20, under 510(k) number K942369.

Who is the listed applicant for GAMMA-BCT INTACT PTH?

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

What is the FDA product code for GAMMA-BCT INTACT PTH?

The FDA product code for GAMMA-BCT INTACT PTH is CEW.

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Other records listing Immunodiagnostic Systems , Ltd. 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.

K202136IDS CortisolK200475IDS-iSYS Ostase BAPK190121IDS SHBGK161158IDS-iSYS Intact PTHNK161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetK161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers

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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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