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FDA 510(k)

HEMOGLOBIN CONTROL

K-Number: K802568 · 1980-11-12

ApplicantMarilyn L. Amick
Decision Date1980-11-12
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Marilyn L. Amick. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802568. 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 CONTROL?

HEMOGLOBIN CONTROL is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Marilyn L. Amick. The 510(k) number is K802568.

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

HEMOGLOBIN CONTROL received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802568.

Who is the listed applicant for HEMOGLOBIN CONTROL?

The FDA 510(k) record lists Marilyn L. Amick as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOGLOBIN CONTROL?

The FDA product code for HEMOGLOBIN CONTROL is KHG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Marilyn L. Amick 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.

K802569ABNORMAL HEMOGLOBIN CONTROLK781544EPPENDORF PCP 6121

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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