Ptt-Lt Test Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K941210 ↗

FDA Product Code

GGW

Device Class

Class II

Regulation

21 CFR Part 864.7925

Advisory Committee

Hematology

FDA Decision

SESK Substantially Equivalent — Kit

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See all devices from American Bioproducts Co. →

• What is the primary function of the PTT-LT Test Kit?

  The PTT-LT Test Kit is a hematology device used to measure the partial thromboplastin time. This measurement determines the time required for a blood sample to clot, which is a standard diagnostic procedure in clinical hematology.

• Is this device cleared for clinical use?

  Yes, the PTT-LT Test Kit is identified by FDA 510(k) clearance number K941210. This indicates that the device has undergone the traditional 510(k) regulatory process and is classified under regulation number 864.7925.

• Who is the manufacturer of the PTT-LT Test Kit?

  The PTT-LT Test Kit is manufactured by American Bioproducts Co., located in Parsippany, New Jersey. The company is the applicant of record for the device's FDA clearance.