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FDA 510(k)

CD-CHEX CD4 LOW

K-Number: K931825 · 1994-06-06

ApplicantStreck Laboratories, Inc.
Decision Date1994-06-06
Product CodeGGL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CD-CHEX CD4 LOW 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 1994-06-06 under 510(k) number K931825. 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 CD4 LOW?

CD-CHEX CD4 LOW is a medical device that received FDA 510(k) clearance on 1994-06-06. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K931825.

When did CD-CHEX CD4 LOW receive FDA 510(k) clearance?

CD-CHEX CD4 LOW received FDA 510(k) clearance on 1994-06-06, under 510(k) number K931825.

Who is the listed applicant for CD-CHEX CD4 LOW?

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 CD4 LOW?

The FDA product code for CD-CHEX CD4 LOW 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-DYNK040107CYTO-CHEX BCTK040025A1C-CELLULARK023656SICKLE-CHEX SOLUBILITY KITK021922MODIFICATION TO PARA 5XK020469CAL-CHEX CD PLUS

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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.

K083926CD4 COUNTStreckK051633CD-CHEX PLUS BCStreckK993126CD-CHEX CD 34Streck Laboratories, Inc.K960894CD-CHEX + RBCStreck 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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