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FDA 510(k)

CD4 COUNT

K-Number: K083926 · 2009-02-11

ApplicantStreck
Decision Date2009-02-11
Product CodeGGL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CD4 COUNT is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2009-02-11 under 510(k) number K083926. 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 CD4 COUNT?

CD4 COUNT is a medical device that received FDA 510(k) clearance on 2009-02-11. The listed applicant is Streck. The 510(k) number is K083926.

When did CD4 COUNT receive FDA 510(k) clearance?

CD4 COUNT received FDA 510(k) clearance on 2009-02-11, under 510(k) number K083926.

Who is the listed applicant for CD4 COUNT?

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 CD4 COUNT?

The FDA product code for CD4 COUNT is GGL.

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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 BCNK231221MDx-Chex for BC-GPK231223MDx-Chex for BC-GNK170091UA-Cellular CompleteK160585XN CALK160590XN CHECK

View all 28 devices →

Related Devices (Code: GGL)

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.

K051633CD-CHEX PLUS BCStreckK993126CD-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.

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