FDA 510(k)

BIOTRACK APTT REAGENT CARTRIDGE

K-Number: K890052 · 1989-02-24

Decision Date1989-02-24

Product CodeGFO

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

BIOTRACK APTT REAGENT CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Biotrack, Inc.. It received FDA 510(k) clearance on 1989-02-24 under 510(k) number K890052. 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 BIOTRACK APTT REAGENT CARTRIDGE?

BIOTRACK APTT REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1989-02-24. The listed applicant is Biotrack, Inc.. The 510(k) number is K890052.

When did BIOTRACK APTT REAGENT CARTRIDGE receive FDA 510(k) clearance?

BIOTRACK APTT REAGENT CARTRIDGE received FDA 510(k) clearance on 1989-02-24, under 510(k) number K890052.

Who is the listed applicant for BIOTRACK APTT REAGENT CARTRIDGE?

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

What is the FDA product code for BIOTRACK APTT REAGENT CARTRIDGE?

The FDA product code for BIOTRACK APTT REAGENT CARTRIDGE 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_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 Biotrack, Inc. as applicant

K934061BIOTRACK VALPROIC ACID TEST CARTRIDGE K934062BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS K920525BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL K915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGE K915755BIOTRACK PHENYTOIN TEST CARTRIDGE K903924BIOTRACK THEOPHYLLINE QUALITY CONTROLS

View all 16 devices →

Related Devices (Code: GFO)

K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.K193556Cryocheck Hex LAPrecision Biologic K160445HemosIL Silica Clotting TimeInstrumentation Laboratory CO K053111STA-CEPHASCREEN KITDiagnostica Stago, Inc.K060688HEMOSIL SYNTHASILInstrumentation Laboratory CO K050221HEMOSIL 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.