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FDA 510(k)

AXSYM INTACT PTH, MODEL 2G06

K-Number: K020945 · 2002-05-31

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date2002-05-31
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXSYM INTACT PTH, MODEL 2G06 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 2002-05-31 under 510(k) number K020945. 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 AXSYM INTACT PTH, MODEL 2G06?

AXSYM INTACT PTH, MODEL 2G06 is a medical device that received FDA 510(k) clearance on 2002-05-31. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K020945.

When did AXSYM INTACT PTH, MODEL 2G06 receive FDA 510(k) clearance?

AXSYM INTACT PTH, MODEL 2G06 received FDA 510(k) clearance on 2002-05-31, under 510(k) number K020945.

Who is the listed applicant for AXSYM INTACT PTH, MODEL 2G06?

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

What is the FDA product code for AXSYM INTACT PTH, MODEL 2G06?

The FDA product code for AXSYM INTACT PTH, MODEL 2G06 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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