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FDA 510(k)

SICKLE CELL REAGENT SET

K-Number: K842368 · 1984-07-20

ApplicantLivonia Diagnostics, Inc.
Decision Date1984-07-20
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 Livonia Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-07-20 under 510(k) number K842368. 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 1984-07-20. The listed applicant is Livonia Diagnostics, Inc.. The 510(k) number is K842368.

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

SICKLE CELL REAGENT SET received FDA 510(k) clearance on 1984-07-20, under 510(k) number K842368.

Who is the listed applicant for SICKLE CELL REAGENT SET?

The FDA 510(k) record lists Livonia Diagnostics, 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.

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Other records listing Livonia Diagnostics, 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.

K852161SERUM IRON/VIBC REAGENT SETK844322SGOT REAGENT SETK844283SGPT REAGENT SETK844237ALKALINE PHOSPHATASE REAGENT SETK844156UREA NITROGEN REAGENT SETK844182INORGANIC PHOSPHORUS REAGENT SET

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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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