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FDA 510(k)

VITROS IMMUNODIAGNOSTIC SYSTEM

K-Number: K962919 · 1996-10-18

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.
Decision Date1996-10-18
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTIC SYSTEM 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 1996-10-18 under 510(k) number K962919. The device is classified under product code KHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS IMMUNODIAGNOSTIC SYSTEM?

VITROS IMMUNODIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K962919.

When did VITROS IMMUNODIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

VITROS IMMUNODIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1996-10-18, under 510(k) number K962919.

Who is the listed applicant for VITROS IMMUNODIAGNOSTIC SYSTEM?

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 SYSTEM?

The FDA product code for VITROS IMMUNODIAGNOSTIC SYSTEM is KHO.

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: KHO)

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.

K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical ApsK973547TRIAGE STATMETERBiosite IncorporatedK971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.K950415FLUOROSCAN NEONATALIsolab, Inc.K935047AUTO DELFIAWallac OY

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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