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FDA 510(k)

ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT

K-Number: K860823 · 1986-08-19

ApplicantCis-Us, Inc.
Decision Date1986-08-19
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT 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 1986-08-19 under 510(k) number K860823. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT?

ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Cis-Us, Inc.. The 510(k) number is K860823.

When did ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT receive FDA 510(k) clearance?

ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT received FDA 510(k) clearance on 1986-08-19, under 510(k) number K860823.

Who is the listed applicant for ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT?

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-PROL IMMUNORADIOMETRIC ASSAY KIT?

The FDA product code for ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT is CFT.

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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-HCTK950211ELSA-PTHK890799CURIETRON 192 HIGH DOSE RATEK882449CESIUM 137 SOURCE, MODEL CSM-40K871502PERSONNEL PROTECTIVE SHIELDK865027IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C

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Related Devices (Code: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, 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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