Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEMOSITE TEST SYSTEM

K-Number: K994073 · 2000-01-14

ApplicantGds Technology, LLC
Decision Date2000-01-14
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSITE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gds Technology, LLC. It received FDA 510(k) clearance on 2000-01-14 under 510(k) number K994073. 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 HEMOSITE TEST SYSTEM?

HEMOSITE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2000-01-14. The listed applicant is Gds Technology, LLC. The 510(k) number is K994073.

When did HEMOSITE TEST SYSTEM receive FDA 510(k) clearance?

HEMOSITE TEST SYSTEM received FDA 510(k) clearance on 2000-01-14, under 510(k) number K994073.

Who is the listed applicant for HEMOSITE TEST SYSTEM?

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

What is the FDA product code for HEMOSITE TEST SYSTEM?

The FDA product code for HEMOSITE TEST SYSTEM 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 Gds Technology, LLC 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.

K992132CHOLESITE TEST SYSTEMK973649HEMOSITE TEST SYSTEMK971145GLUCOSITE TEST SYSTEMK911801KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CONK882038GDS ENZYMATIC SALICYLATE REAGENTK880829GDS ENZYMATIC ACETAMINOPHEN REAGENT

View all 7 devices →

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.K973649HEMOSITE 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.

↑