FDA 510(k)

FACTOR XI DEFICIENT PLASMA B11D

K-Number: K843438 · 1984-11-19

Decision Date1984-11-19

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FACTOR XI DEFICIENT PLASMA B11D is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1984-11-19 under 510(k) number K843438. 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 FACTOR XI DEFICIENT PLASMA B11D?

FACTOR XI DEFICIENT PLASMA B11D is a medical device that received FDA 510(k) clearance on 1984-11-19. The listed applicant is Sigma Chemical Co.. The 510(k) number is K843438.

When did FACTOR XI DEFICIENT PLASMA B11D receive FDA 510(k) clearance?

FACTOR XI DEFICIENT PLASMA B11D received FDA 510(k) clearance on 1984-11-19, under 510(k) number K843438.

Who is the listed applicant for FACTOR XI DEFICIENT PLASMA B11D?

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

What is the FDA product code for FACTOR XI DEFICIENT PLASMA B11D?

The FDA product code for FACTOR XI DEFICIENT PLASMA B11D 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 Sigma Chemical Co. as applicant

K933694SIGMA GLUCOSE REAGENT K933678SIGMA CALCIUM REAGENT K933696SIGMA ELECTROLYTE REFERENCE REAGENT K933691SIGMA CO2 ALKALINE BUFFER REAGENT K933679SIGMA BUN REAGENT K933703SIGMA WASH CONCENTRATE SOLUTION

View all 231 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.