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510(k) K870596

PROTHROMBIN TIME TEST by U. S. Diagnostics, Inc. — Product Code GJS

K870596 is an FDA 510(k) premarket notification submitted by U. S. Diagnostics, Inc. for the device "PROTHROMBIN TIME TEST". The FDA issued a decision of Substantially Equivalent on April 20, 1987. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. U. S. Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1987
Date Received
February 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

Other clearances by U. S. Diagnostics, Inc.

  • K110435 — EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM (September 21, 2011)
  • K082201 — G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A (February 20, 2009)
  • K061431 — EASYGLUCO, MODEL IGM-0002 G2 (January 12, 2007)
  • K051651 — G4, MODEL IGM-0004 (April 14, 2006)
  • K870685 — COAGULATION CONTROL, LEVEL I (April 20, 1987)
  • K870686 — COAGULATION CONTROL, LEVEL II (April 20, 1987)
  • K870687 — COAGULATION CONTROL, LEVEL III (April 20, 1987)
  • K871283 — CYANMETHEMOGLOBIN STANDARD (April 15, 1987)
  • K870737 — U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL (April 13, 1987)
  • K870738 — U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL (April 13, 1987)

Other clearances for product code GJS

  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K251564 — microINR System (July 21, 2025)
  • K243543 — microINR System (February 27, 2025)
  • K230802 — Xprecia Prime Coagulation System (March 15, 2024)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K231711 — microINR System (July 11, 2023)
  • K211485 — STA- NeoPTimal (December 23, 2022)
  • K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (October 5, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)
  • K201185 — microINR System (December 18, 2020)

FDA data resources