FDA 510(k)

CD-CHEX CD 34

K-Number: K993126 · 1999-11-26

Decision Date1999-11-26

Product CodeGGL

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CD-CHEX CD 34 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 1999-11-26 under 510(k) number K993126. 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 CD 34?

CD-CHEX CD 34 is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K993126.

When did CD-CHEX CD 34 receive FDA 510(k) clearance?

CD-CHEX CD 34 received FDA 510(k) clearance on 1999-11-26, under 510(k) number K993126.

Who is the listed applicant for CD-CHEX CD 34?

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 CD-CHEX CD 34?

The FDA product code for CD-CHEX CD 34 is GGL.

Other records listing Streck Laboratories, 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.

K042587RETIC-CHEX FOR CELL-DYN K040107CYTO-CHEX BCT K040025A1C-CELLULAR K023656SICKLE-CHEX SOLUBILITY KIT K021922MODIFICATION TO PARA 5X K020469CAL-CHEX CD PLUS

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Related Devices (Code: GGL)

K083926CD4 COUNTStreck K051633CD-CHEX PLUS BCStreck 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.