FDA 510(k)

CD-CHEX

K-Number: K920997 · 1992-05-31

Decision Date1992-05-31

Product CodeGGL

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CD-CHEX 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 1992-05-31 under 510(k) number K920997. 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-CHEX is a medical device that received FDA 510(k) clearance on 1992-05-31. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K920997.

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

CD-CHEX received FDA 510(k) clearance on 1992-05-31, under 510(k) number K920997.

Who is the listed applicant for CD-CHEX?

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?

The FDA product code for CD-CHEX 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 K993126CD-CHEX CD 34Streck Laboratories, Inc.K960894CD-CHEX + RBCStreck Laboratories, Inc.K931825CD-CHEX CD4 LOWStreck 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.