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FDA 510(k)

HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD

K-Number: K870363 · 1987-03-16

ApplicantTrace Scientific , Ltd.
Decision Date1987-03-16
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K870363. 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 HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD?

HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K870363.

When did HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD receive FDA 510(k) clearance?

HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD received FDA 510(k) clearance on 1987-03-16, under 510(k) number K870363.

Who is the listed applicant for HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD?

The FDA product code for HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD is KHG.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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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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