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FDA 510(k)

VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)

K-Number: K970643 · 1997-03-18

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.
Decision Date1997-03-18
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) 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 1997-03-18 under 510(k) number K970643. The device is classified under product code CHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)?

VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K970643.

When did VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) receive FDA 510(k) clearance?

VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) received FDA 510(k) clearance on 1997-03-18, under 510(k) number K970643.

Who is the listed applicant for VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)?

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 IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)?

The FDA product code for VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) is CHP.

Related Clinical Trials

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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Other records listing Johnson & Johnson Clinical Diagnostics, 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.

K980283VITROS CHEMISTRY PRODUCTS CRBM SLIDESK974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSK973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSK973030VITROS 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)

View all 33 devices →

Related Devices (Code: CHP)

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.

K041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMIbl GmbHK97390117 B-ESTRADIOL (ELISA)Kmi Diagnostics, Inc.K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.K970386ACS ESTADIOL-6 IIChiron Diagnostics Corp.K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad Laboratories, Inc.K965109ELECSYS ESTRADIOL ASSAYBoehringer Mannheim Corp.

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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