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FDA 510(k)

ELSA-HCT

K-Number: K951708 · 1995-09-05

ApplicantCis-Us, Inc.
Decision Date1995-09-05
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELSA-HCT 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 1995-09-05 under 510(k) number K951708. The device is classified under product code JKR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELSA-HCT?

ELSA-HCT is a medical device that received FDA 510(k) clearance on 1995-09-05. The listed applicant is Cis-Us, Inc.. The 510(k) number is K951708.

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

ELSA-HCT received FDA 510(k) clearance on 1995-09-05, under 510(k) number K951708.

Who is the listed applicant for ELSA-HCT?

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-HCT?

The FDA product code for ELSA-HCT is JKR.

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.

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Related Devices (Code: JKR)

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.

K252431Elecsys CalcitoninRoche Diagnostics GmbHK182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics LimitedK132828ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3Roche DiagnosticsK060578CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)Scantibodies Laboratory, Inc.K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCLDiagnostic Products Corp.K990073CALCITONINKmi Diagnostics, Inc.

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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