FDA 510(k)

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

K-Number: K001022 · 2000-09-26

Decision Date2000-09-26

Product CodeJZG

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 2000-09-26 under 510(k) number K001022. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061?

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 is a medical device that received FDA 510(k) clearance on 2000-09-26. The listed applicant is Biocheck, Inc.. The 510(k) number is K001022.

When did BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 receive FDA 510(k) clearance?

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 received FDA 510(k) clearance on 2000-09-26, under 510(k) number K001022.

Who is the listed applicant for BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061?

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

What is the FDA product code for BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061?

The FDA product code for BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 is JZG.

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Related Devices (Code: JZG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.