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FDA 510(k)

ELSA-PTH

K-Number: K950211 · 1995-04-13

ApplicantCis-Us, Inc.
Decision Date1995-04-13
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELSA-PTH is the device name listed in this FDA 510(k) record. The listed applicant is Cis-Us, Inc.. It received FDA 510(k) clearance on 1995-04-13 under 510(k) number K950211. 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 ELSA-PTH?

ELSA-PTH is a medical device that received FDA 510(k) clearance on 1995-04-13. The listed applicant is Cis-Us, Inc.. The 510(k) number is K950211.

When did ELSA-PTH receive FDA 510(k) clearance?

ELSA-PTH received FDA 510(k) clearance on 1995-04-13, under 510(k) number K950211.

Who is the listed applicant for ELSA-PTH?

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

What is the FDA product code for ELSA-PTH?

The FDA product code for ELSA-PTH is CEW.

Other records listing Cis-Us, Inc. 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.

K951708ELSA-HCTK890799CURIETRON 192 HIGH DOSE RATEK882449CESIUM 137 SOURCE, MODEL CSM-40K871502PERSONNEL PROTECTIVE SHIELDK865027IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137CK863778VENTICIS II

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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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