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FDA 510(k)

OCTEIA INTACT PTH

K-Number: K941878 · 1994-09-07

ApplicantI.D.S.
Decision Date1994-09-07
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OCTEIA INTACT PTH is the device name listed in this FDA 510(k) record. The listed applicant is I.D.S.. It received FDA 510(k) clearance on 1994-09-07 under 510(k) number K941878. 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 OCTEIA INTACT PTH?

OCTEIA INTACT PTH is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is I.D.S.. The 510(k) number is K941878.

When did OCTEIA INTACT PTH receive FDA 510(k) clearance?

OCTEIA INTACT PTH received FDA 510(k) clearance on 1994-09-07, under 510(k) number K941878.

Who is the listed applicant for OCTEIA INTACT PTH?

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

What is the FDA product code for OCTEIA INTACT PTH?

The FDA product code for OCTEIA INTACT PTH 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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