Careside PT

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K991065 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Careside Amylase

  Class II

  FDA 510(k) K990025 Active Cleared 8 Feb 1999

• Careside Total Bilirubin

  Class II

  FDA 510(k) K981588 Active Cleared 23 Jun 1998

• Careside Direct Bilirubin

  Class II

  FDA 510(k) K993771 Active Cleared 27 Dec 1999

• Careside Analyzer

  Class I

  FDA 510(k) K981610 Active Cleared 25 Jun 1998

• Careside Ckmb

  Class II

  FDA 510(k) K990434 Active Cleared 19 Apr 1999

• Careside Hemoglobin

  Class II

  FDA 510(k) K001462 Active Cleared 21 Aug 2000

See all devices from Careside, Inc. →

• What is the CARESIDE PT used for?

  The CARESIDE PT is a Test, Time, Prothrombin test system intended for use in hematology testing, as stated in its device description and classification under medical specialty hematology.

• How is the CARESIDE PT supplied or authorized for use?

  The CARESIDE PT is authorized through FDA 510(k) clearance K991065, obtained via the traditional pathway, and is classified as a Class II device under regulation number 864.7750 with product code GJS.

• Is the CARESIDE PT a new or equivalent device?

  The CARESIDE PT was determined to be substantially equivalent (SESE) to a predicate device, as indicated by its decision code and decision description in the FDA 510(k) authorization.