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FDA 510(k)

BIOCHECK TESTOSTERONE EIA, MODEL BC-1115

K-Number: K002294 · 2000-10-02

ApplicantBiocheck, Inc.
Decision Date2000-10-02
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 2000-10-02 under 510(k) number K002294. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHECK TESTOSTERONE EIA, MODEL BC-1115?

BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 is a medical device that received FDA 510(k) clearance on 2000-10-02. The listed applicant is Biocheck, Inc.. The 510(k) number is K002294.

When did BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 receive FDA 510(k) clearance?

BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 received FDA 510(k) clearance on 2000-10-02, under 510(k) number K002294.

Who is the listed applicant for BIOCHECK TESTOSTERONE EIA, MODEL BC-1115?

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 TESTOSTERONE EIA, MODEL BC-1115?

The FDA product code for BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 is CDZ.

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Other records listing Biocheck, 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.

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Related Devices (Code: CDZ)

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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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