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FDA 510(k)

MONOJECT SICKLE CELL KIT

K-Number: K791971 · 1979-11-05

ApplicantSherwood Medical Co.
Decision Date1979-11-05
Product CodeGHM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MONOJECT SICKLE CELL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K791971. 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 MONOJECT SICKLE CELL KIT?

MONOJECT SICKLE CELL KIT is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Sherwood Medical Co.. The 510(k) number is K791971.

When did MONOJECT SICKLE CELL KIT receive FDA 510(k) clearance?

MONOJECT SICKLE CELL KIT received FDA 510(k) clearance on 1979-11-05, under 510(k) number K791971.

Who is the listed applicant for MONOJECT SICKLE CELL KIT?

The FDA 510(k) record lists Sherwood Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOJECT SICKLE CELL KIT?

The FDA product code for MONOJECT SICKLE CELL KIT is GHM.

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Other records listing Sherwood Medical Co. 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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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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