FDA 510(k)

CD-CHEX PLUS BC

K-Number: K051633 · 2005-08-16

ApplicantStreck

Decision Date2005-08-16

Product CodeGGL

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CD-CHEX PLUS BC is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2005-08-16 under 510(k) number K051633. The device is classified under product code GGL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CD-CHEX PLUS BC?

CD-CHEX PLUS BC is a medical device that received FDA 510(k) clearance on 2005-08-16. The listed applicant is Streck. The 510(k) number is K051633.

When did CD-CHEX PLUS BC receive FDA 510(k) clearance?

CD-CHEX PLUS BC received FDA 510(k) clearance on 2005-08-16, under 510(k) number K051633.

Who is the listed applicant for CD-CHEX PLUS BC?

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

What is the FDA product code for CD-CHEX PLUS BC?

The FDA product code for CD-CHEX PLUS BC is GGL.

Other records listing Streck 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.

K254166MDx-Chex for BCN K231223MDx-Chex for BC-GN K231221MDx-Chex for BC-GP K170091UA-Cellular Complete K160585XN CAL K160586XN-L CHECK

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Related Devices (Code: GGL)

K083926CD4 COUNTStreck K993126CD-CHEX CD 34Streck Laboratories, Inc.K960894CD-CHEX + RBCStreck Laboratories, Inc.K931825CD-CHEX CD4 LOWStreck Laboratories, Inc.K920997CD-CHEXStreck Laboratories, Inc.K894651COULTER POSITIVE CONTROL CELLSCoulter Corp.

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.