FDA 510(k)

THE STAGO VIII DEFICIENT PLASMA KIT

K-Number: K892859 · 1989-06-23

Decision Date1989-06-23

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

THE STAGO VIII DEFICIENT PLASMA 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 1989-06-23 under 510(k) number K892859. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE STAGO VIII DEFICIENT PLASMA KIT?

THE STAGO VIII DEFICIENT PLASMA KIT is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is American Bioproducts Co.. The 510(k) number is K892859.

When did THE STAGO VIII DEFICIENT PLASMA KIT receive FDA 510(k) clearance?

THE STAGO VIII DEFICIENT PLASMA KIT received FDA 510(k) clearance on 1989-06-23, under 510(k) number K892859.

Who is the listed applicant for THE STAGO VIII DEFICIENT PLASMA 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 THE STAGO VIII DEFICIENT PLASMA KIT?

The FDA product code for THE STAGO VIII DEFICIENT PLASMA KIT is GGP.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Bioproducts Co. as applicant

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZER K971519ASSERACHROM TPA TEST KIT K964728STA-LIATEST D-DI TEST KIT K964716STA LIATEST CONTROL [N]+[P] KIT K964718STA D-DI CALIBRATOR KIT K962675STA - LIATEST VWF TEST KIT

View all 79 devices →

Related Devices (Code: GGP)

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company K220728vWF AgSiemens Healthcare Diagnostics Products GmbH K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO K200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

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.