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)

COATEST PROTEIN C

K-Number: K884058 · 1988-12-13

ApplicantKabivitrum, Inc.
Decision Date1988-12-13
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COATEST PROTEIN C is the device name listed in this FDA 510(k) record. The listed applicant is Kabivitrum, Inc.. It received FDA 510(k) clearance on 1988-12-13 under 510(k) number K884058. 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 COATEST PROTEIN C?

COATEST PROTEIN C is a medical device that received FDA 510(k) clearance on 1988-12-13. The listed applicant is Kabivitrum, Inc.. The 510(k) number is K884058.

When did COATEST PROTEIN C receive FDA 510(k) clearance?

COATEST PROTEIN C received FDA 510(k) clearance on 1988-12-13, under 510(k) number K884058.

Who is the listed applicant for COATEST PROTEIN C?

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

What is the FDA product code for COATEST PROTEIN C?

The FDA product code for COATEST PROTEIN C 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_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 Kabivitrum, 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.

K854572COATEST PLASMINOGENK844664THE I.V. BAGK833890COATEST ANTIPLASMINK833892COATEST FACTOR VIIIK833891COATEST HEPARINK832114COATEST FACTOR X

View all 8 devices →

Related Devices (Code: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL 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.

↑