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)

THROMBOMAX-HS WITH CALCIUM, MODEL T6540

K-Number: K010158 · 2001-03-22

ApplicantSigma Diagnostics, Inc.
Decision Date2001-03-22
Product CodeGGO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOMAX-HS WITH CALCIUM, MODEL T6540 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-03-22 under 510(k) number K010158. The device is classified under product code GGO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOMAX-HS WITH CALCIUM, MODEL T6540?

THROMBOMAX-HS WITH CALCIUM, MODEL T6540 is a medical device that received FDA 510(k) clearance on 2001-03-22. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K010158.

When did THROMBOMAX-HS WITH CALCIUM, MODEL T6540 receive FDA 510(k) clearance?

THROMBOMAX-HS WITH CALCIUM, MODEL T6540 received FDA 510(k) clearance on 2001-03-22, under 510(k) number K010158.

Who is the listed applicant for THROMBOMAX-HS WITH CALCIUM, MODEL T6540?

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

What is the FDA product code for THROMBOMAX-HS WITH CALCIUM, MODEL T6540?

The FDA product code for THROMBOMAX-HS WITH CALCIUM, MODEL T6540 is GGO.

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 Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

View all 164 devices →

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.

↑