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FDA 510(k)

VITROS CHEMISTRY PRODUCTS UPRO SLIDES

K-Number: K964960 · 1997-02-18

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.
Decision Date1997-02-18
Product CodeJGP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS UPRO SLIDES 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 1997-02-18 under 510(k) number K964960. The device is classified under product code JGP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS CHEMISTRY PRODUCTS UPRO SLIDES?

VITROS CHEMISTRY PRODUCTS UPRO SLIDES is a medical device that received FDA 510(k) clearance on 1997-02-18. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K964960.

When did VITROS CHEMISTRY PRODUCTS UPRO SLIDES receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS UPRO SLIDES received FDA 510(k) clearance on 1997-02-18, under 510(k) number K964960.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS UPRO SLIDES?

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 CHEMISTRY PRODUCTS UPRO SLIDES?

The FDA product code for VITROS CHEMISTRY PRODUCTS UPRO SLIDES is JGP.

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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)

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Related Devices (Code: JGP)

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.

K070757MICROPROTEIN REAGENT SETPointe Scientific, Inc.,K863112PROTEINMETERJ. D. Assoc.K821534HEMATOLOGY DATA MANAGEMENT SYSBiovation, Inc.K792347MICRO LOWRY PROTEINTESTPanmed, 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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