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)

STA LIATEST CONTROL [N]+[P] KIT

K-Number: K964716 · 1997-06-26

ApplicantAmerican Bioproducts Co.
Decision Date1997-06-26
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA LIATEST CONTROL [N]+[P] KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1997-06-26 under 510(k) number K964716. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA LIATEST CONTROL [N]+[P] KIT?

STA LIATEST CONTROL [N]+[P] KIT is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is American Bioproducts Co.. The 510(k) number is K964716.

When did STA LIATEST CONTROL [N]+[P] KIT receive FDA 510(k) clearance?

STA LIATEST CONTROL [N]+[P] KIT received FDA 510(k) clearance on 1997-06-26, under 510(k) number K964716.

Who is the listed applicant for STA LIATEST CONTROL [N]+[P] KIT?

The FDA 510(k) record lists American Bioproducts Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STA LIATEST CONTROL [N]+[P] KIT?

The FDA product code for STA LIATEST CONTROL [N]+[P] KIT is GGN.

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 American Bioproducts Co. 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.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERK971519ASSERACHROM TPA TEST KITK964728STA-LIATEST D-DI TEST KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KITK962671STA-VWF CALIBRATOR KIT

View all 79 devices →

Related Devices (Code: GGN)

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.

K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLCK163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLCK161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc.K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLCK152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLCK150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, Inc.

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.

↑