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FDA 510(k)

SICKLE-CHEX

K-Number: K013316 · 2001-11-06

ApplicantStreck Laboratories, Inc.
Decision Date2001-11-06
Product CodeGHM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SICKLE-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 2001-11-06 under 510(k) number K013316. 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?

SICKLE-CHEX is a medical device that received FDA 510(k) clearance on 2001-11-06. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K013316.

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

SICKLE-CHEX received FDA 510(k) clearance on 2001-11-06, under 510(k) number K013316.

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

The FDA product code for SICKLE-CHEX is GHM.

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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-CELLULARK023656SICKLE-CHEX SOLUBILITY KITK021922MODIFICATION TO PARA 5XK020469CAL-CHEX CD PLUS

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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.

K023656SICKLE-CHEX SOLUBILITY KITStreck 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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