FDA 510(k)

SICKLE-HEME A/S CONTROLS & A/A CONTROL

K-Number: K831871 · 1983-07-28

Decision Date1983-07-28

Product CodeGHM

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

SICKLE-HEME A/S CONTROLS & A/A CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1983-07-28 under 510(k) number K831871. 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-HEME A/S CONTROLS & A/A CONTROL?

SICKLE-HEME A/S CONTROLS & A/A CONTROL is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K831871.

When did SICKLE-HEME A/S CONTROLS & A/A CONTROL receive FDA 510(k) clearance?

SICKLE-HEME A/S CONTROLS & A/A CONTROL received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831871.

Who is the listed applicant for SICKLE-HEME A/S CONTROLS & A/A CONTROL?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SICKLE-HEME A/S CONTROLS & A/A CONTROL?

The FDA product code for SICKLE-HEME A/S CONTROLS & A/A CONTROL is GHM.

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Other records listing Anco Medical Reagents & Assoc. as applicant

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH K821658HEMOGLOBIN REAGENT K821526ACID PHOSPHATASE REAGENT SET K821102MEGNESIUM REAGENT KIT K820951ENZYMATIC CHOLESTEROL KIT K820466SGOT REAGENT SET

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Related Devices (Code: GHM)

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.