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FDA 510(k)

SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH

K-Number: K842440 · 1984-07-27

ApplicantAnco Medical Reagents & Assoc.
Decision Date1984-07-27
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH 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 1984-07-27 under 510(k) number K842440. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH?

SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH is a medical device that received FDA 510(k) clearance on 1984-07-27. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K842440.

When did SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH receive FDA 510(k) clearance?

SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH received FDA 510(k) clearance on 1984-07-27, under 510(k) number K842440.

Who is the listed applicant for SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH?

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 CELL STAT A/S HETEROZYGOUS-ERYTH?

The FDA product code for SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH is JPK.

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Other records listing Anco Medical Reagents & Assoc. 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.

K831871SICKLE-HEME A/S CONTROLS & A/A CONTROLK821658HEMOGLOBIN REAGENTK821526ACID PHOSPHATASE REAGENT SETK821102MEGNESIUM REAGENT KITK820951ENZYMATIC CHOLESTEROL KITK820466SGOT REAGENT SET

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Related Devices (Code: JPK)

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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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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