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FDA 510(k)

SICKLE-STAT HEMOGLOBIN S SCREEN KIT

K-Number: K841272 · 1984-04-13

ApplicantClinical Technology Corp.
Decision Date1984-04-13
Product CodeGHM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SICKLE-STAT HEMOGLOBIN S SCREEN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Technology Corp.. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K841272. 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-STAT HEMOGLOBIN S SCREEN KIT?

SICKLE-STAT HEMOGLOBIN S SCREEN KIT is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is Clinical Technology Corp.. The 510(k) number is K841272.

When did SICKLE-STAT HEMOGLOBIN S SCREEN KIT receive FDA 510(k) clearance?

SICKLE-STAT HEMOGLOBIN S SCREEN KIT received FDA 510(k) clearance on 1984-04-13, under 510(k) number K841272.

Who is the listed applicant for SICKLE-STAT HEMOGLOBIN S SCREEN KIT?

The FDA 510(k) record lists Clinical Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SICKLE-STAT HEMOGLOBIN S SCREEN KIT?

The FDA product code for SICKLE-STAT HEMOGLOBIN S SCREEN KIT is GHM.

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Other records listing Clinical Technology Corp. 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.

K925080TEK-LUBEK872867BIOSIGNK880166BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000K872705BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)K855138BOVIE ULTRASONIC SURGICAL SYSTEMK854231ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES

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

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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