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FDA 510(k)

APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT

K-Number: K950383 · 1995-09-15

ApplicantRandox Laboratories, Ltd.
Decision Date1995-09-15
Product CodeJHN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K950383. 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 APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT?

APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K950383.

When did APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT receive FDA 510(k) clearance?

APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT received FDA 510(k) clearance on 1995-09-15, under 510(k) number K950383.

Who is the listed applicant for APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT?

The FDA product code for APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT is JHN.

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Other records listing Randox Laboratories, Ltd. 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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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.

K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITRandox Laboratories, Ltd.K952615WAKO AUTOKIT APO A1Wako Chemicals USA, Inc.K952425OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K952466OLYMPUS APOLIPOPROTEIN B 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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