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FDA 510(k)

CYTO-CHEX BCT

K-Number: K040107 · 2004-07-27

ApplicantStreck Laboratories, Inc.
Decision Date2004-07-27
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CYTO-CHEX BCT is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 2004-07-27 under 510(k) number K040107. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTO-CHEX BCT?

CYTO-CHEX BCT is a medical device that received FDA 510(k) clearance on 2004-07-27. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K040107.

When did CYTO-CHEX BCT receive FDA 510(k) clearance?

CYTO-CHEX BCT received FDA 510(k) clearance on 2004-07-27, under 510(k) number K040107.

Who is the listed applicant for CYTO-CHEX BCT?

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

What is the FDA product code for CYTO-CHEX BCT?

The FDA product code for CYTO-CHEX BCT is JKA.

Other records listing Streck Laboratories, Inc. as applicant

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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.

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