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FDA 510(k)

HEMOGLOBIN REAGENT

K-Number: K821658 · 1982-06-25

ApplicantAnco Medical Reagents & Assoc.
Decision Date1982-06-25
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN REAGENT 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 1982-06-25 under 510(k) number K821658. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGLOBIN REAGENT?

HEMOGLOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K821658.

When did HEMOGLOBIN REAGENT receive FDA 510(k) clearance?

HEMOGLOBIN REAGENT received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821658.

Who is the listed applicant for HEMOGLOBIN REAGENT?

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 HEMOGLOBIN REAGENT?

The FDA product code for HEMOGLOBIN REAGENT is KHG.

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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.

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTHK831871SICKLE-HEME A/S CONTROLS & A/A CONTROLK821526ACID PHOSPHATASE REAGENT SETK821102MEGNESIUM REAGENT KITK820951ENZYMATIC CHOLESTEROL KITK820466SGOT REAGENT SET

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Related Devices (Code: KHG)

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.

K221508AnemoCheck HomeSanguina, Inc.K163215AnemoCheckSanguina, LLCK042379ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.K020138STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090Gds TechnologyK001462CARESIDE HEMOGLOBINCareside, Inc.K994073HEMOSITE TEST SYSTEMGds Technology, LLC

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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