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FDA 510(k)

SICKLE CELL REAGENT SET

K-Number: K860812 · 1986-04-11

ApplicantMichclone Associates, Inc.
Decision Date1986-04-11
Product CodeGHM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SICKLE CELL REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Michclone Associates, Inc.. It received FDA 510(k) clearance on 1986-04-11 under 510(k) number K860812. 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 CELL REAGENT SET?

SICKLE CELL REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Michclone Associates, Inc.. The 510(k) number is K860812.

When did SICKLE CELL REAGENT SET receive FDA 510(k) clearance?

SICKLE CELL REAGENT SET received FDA 510(k) clearance on 1986-04-11, under 510(k) number K860812.

Who is the listed applicant for SICKLE CELL REAGENT SET?

The FDA 510(k) record lists Michclone Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SICKLE CELL REAGENT SET?

The FDA product code for SICKLE CELL REAGENT SET 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 Michclone Associates, 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.

K871676ENZYMATIC CHOLESTEROL REAGENT SETK842955SICKLE-HEME A/S HETEROZYGOUS CONTROL

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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