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)

UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

K-Number: K882325 · 1988-08-25

ApplicantSclavo, Inc.
Decision Date1988-08-25
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1988-08-25 under 510(k) number K882325. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST?

UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST is a medical device that received FDA 510(k) clearance on 1988-08-25. The listed applicant is Sclavo, Inc.. The 510(k) number is K882325.

When did UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST receive FDA 510(k) clearance?

UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST received FDA 510(k) clearance on 1988-08-25, under 510(k) number K882325.

Who is the listed applicant for UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST?

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

What is the FDA product code for UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST?

The FDA product code for UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST is GFO.

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 Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

View all 82 devices →

Related Devices (Code: GFO)

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.

K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.K193556Cryocheck Hex LAPrecision BiologicK160445HemosIL Silica Clotting TimeInstrumentation Laboratory COK053111STA-CEPHASCREEN KITDiagnostica Stago, Inc.K060688HEMOSIL SYNTHASILInstrumentation Laboratory COK050221HEMOSIL SILICA CLOTTING TIMEInstrumentation 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.

↑