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FDA 510(k)

IMMULITE/IMMULITE 1000 TURBO INTACT PTH

K-Number: K053533 · 2006-02-03

ApplicantDiagnostic Products Corporation
Decision Date2006-02-03
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE/IMMULITE 1000 TURBO INTACT PTH is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corporation. It received FDA 510(k) clearance on 2006-02-03 under 510(k) number K053533. 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 IMMULITE/IMMULITE 1000 TURBO INTACT PTH?

IMMULITE/IMMULITE 1000 TURBO INTACT PTH is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Diagnostic Products Corporation. The 510(k) number is K053533.

When did IMMULITE/IMMULITE 1000 TURBO INTACT PTH receive FDA 510(k) clearance?

IMMULITE/IMMULITE 1000 TURBO INTACT PTH received FDA 510(k) clearance on 2006-02-03, under 510(k) number K053533.

Who is the listed applicant for IMMULITE/IMMULITE 1000 TURBO INTACT PTH?

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

What is the FDA product code for IMMULITE/IMMULITE 1000 TURBO INTACT PTH?

The FDA product code for IMMULITE/IMMULITE 1000 TURBO INTACT PTH is CEW.

Related Clinical Trials

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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Other records listing Diagnostic Products Corporation 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.

K063057IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRPK060929IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6

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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