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FDA 510(k)

HEMOGLOBIN ANALYZER

K-Number: K851467 · 1985-07-16

ApplicantAwareness Technology, Inc.
Decision Date1985-07-16
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Awareness Technology, Inc.. It received FDA 510(k) clearance on 1985-07-16 under 510(k) number K851467. 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 ANALYZER?

HEMOGLOBIN ANALYZER is a medical device that received FDA 510(k) clearance on 1985-07-16. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K851467.

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

HEMOGLOBIN ANALYZER received FDA 510(k) clearance on 1985-07-16, under 510(k) number K851467.

Who is the listed applicant for HEMOGLOBIN ANALYZER?

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

What is the FDA product code for HEMOGLOBIN ANALYZER?

The FDA product code for HEMOGLOBIN ANALYZER is KHG.

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Other records listing Awareness Technology, 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.

K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)K013420CHEMWELL, ALSO KNOWN AS PROJECT 2900K010877CHEMWELL, MODEL 2900K974762STAT TRACKSK943729DYE CHECK STRIPS 545-630K941394STAT FAX 2600

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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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