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FDA 510(k)

SICKLE-CHEX SOLUBILITY KIT

K-Number: K023656 · 2002-12-30

ApplicantStreck Laboratories, Inc.
Decision Date2002-12-30
Product CodeGHM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SICKLE-CHEX SOLUBILITY KIT 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 2002-12-30 under 510(k) number K023656. The device is classified under product code GHM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SICKLE-CHEX SOLUBILITY KIT?

SICKLE-CHEX SOLUBILITY KIT is a medical device that received FDA 510(k) clearance on 2002-12-30. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K023656.

When did SICKLE-CHEX SOLUBILITY KIT receive FDA 510(k) clearance?

SICKLE-CHEX SOLUBILITY KIT received FDA 510(k) clearance on 2002-12-30, under 510(k) number K023656.

Who is the listed applicant for SICKLE-CHEX SOLUBILITY KIT?

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 SICKLE-CHEX SOLUBILITY KIT?

The FDA product code for SICKLE-CHEX SOLUBILITY KIT is GHM.

Related Clinical Trials

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.

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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-CELLULARK021922MODIFICATION TO PARA 5XK020469CAL-CHEX CD PLUSK013316SICKLE-CHEX

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Related Devices (Code: GHM)

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.

K013316SICKLE-CHEXStreck Laboratories, Inc.K960947SAS SICKLE CELL TESTSa Scientific, Inc.K911981HEMOCARD HEMOGLOBIN SIsolab, Inc.K910430HEMOCARD-ASIsolab, Inc.K872217THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KITPacific HemostasisK860812SICKLE CELL REAGENT SETMichclone Associates, Inc.

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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