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FDA 510(k)

ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953

K-Number: K061190 · 2006-09-15

ApplicantBeckman Coulter, Inc.
Decision Date2006-09-15
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2006-09-15 under 510(k) number K061190. 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 ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953?

ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 is a medical device that received FDA 510(k) clearance on 2006-09-15. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K061190.

When did ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 receive FDA 510(k) clearance?

ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 received FDA 510(k) clearance on 2006-09-15, under 510(k) number K061190.

Who is the listed applicant for ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953?

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

What is the FDA product code for ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953?

The FDA product code for ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 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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