FDA 510(k)

VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS

K-Number: K970281 · 1997-02-25

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.

Decision Date1997-02-25

Product CodeCFT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-02-25 under 510(k) number K970281. 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 VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS?

VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS is a medical device that received FDA 510(k) clearance on 1997-02-25. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K970281.

When did VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS receive FDA 510(k) clearance?

VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS received FDA 510(k) clearance on 1997-02-25, under 510(k) number K970281.

Who is the listed applicant for VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS?

The FDA 510(k) record lists Johnson & Johnson Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS?

The FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS is CFT.

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Other records listing Johnson & Johnson Clinical Diagnostics, Inc. as applicant

K980283VITROS CHEMISTRY PRODUCTS CRBM SLIDES K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS K973030VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)K970894VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)

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Related Devices (Code: CFT)

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobind 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.K954680ACCESS PROLACTIN ASSAY (MODIFICATION)Bio-Rad Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.