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FDA 510(k)

OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT

K-Number: K952466 · 1995-06-05

ApplicantOlympus America, Inc.
Decision Date1995-06-05
Product CodeJHN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1995-06-05 under 510(k) number K952466. The device is classified under product code JHN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT?

OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT is a medical device that received FDA 510(k) clearance on 1995-06-05. The listed applicant is Olympus America, Inc.. The 510(k) number is K952466.

When did OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT receive FDA 510(k) clearance?

OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT received FDA 510(k) clearance on 1995-06-05, under 510(k) number K952466.

Who is the listed applicant for OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT?

The FDA 510(k) record lists Olympus America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT?

The FDA product code for OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT is JHN.

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Other records listing Olympus America, 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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Related Devices (Code: JHN)

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.

K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITRandox Laboratories, Ltd.K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITRandox Laboratories, Ltd.K952615WAKO AUTOKIT APO A1Wako Chemicals USA, Inc.K952425OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K932603APOLIPOPROTIEN B (APO B)Sigma Diagnostics, Inc.K932606APOLIPOPROTIEN A-1 (APO A-1)Sigma Diagnostics, 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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