FDA 510(k)

BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027

K-Number: K991741 · 1999-07-22

Decision Date1999-07-22

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 1999-07-22 under 510(k) number K991741. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027?

BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 is a medical device that received FDA 510(k) clearance on 1999-07-22. The listed applicant is Biocheck, Inc.. The 510(k) number is K991741.

When did BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 receive FDA 510(k) clearance?

BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 received FDA 510(k) clearance on 1999-07-22, under 510(k) number K991741.

Who is the listed applicant for BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027?

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 HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027?

The FDA product code for BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 is JHI.

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Related Devices (Code: JHI)

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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.