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FDA 510(k)

BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117

K-Number: K022660 · 2002-12-19

ApplicantBiocheck, Inc.
Decision Date2002-12-19
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 2002-12-19 under 510(k) number K022660. The device is classified under product code DRR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117?

BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 is a medical device that received FDA 510(k) clearance on 2002-12-19. The listed applicant is Biocheck, Inc.. The 510(k) number is K022660.

When did BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 receive FDA 510(k) clearance?

BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 received FDA 510(k) clearance on 2002-12-19, under 510(k) number K022660.

Who is the listed applicant for BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117?

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 MYOGLOBIN ELISA, MODEL BC-1117?

The FDA product code for BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 is DRR.

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Other records listing Biocheck, Inc. as applicant

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Related Devices (Code: DRR)

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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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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