PROTHROMBIN TIME TEST— 510(k) K872537

Name: FDA 510(k) clearance K872537
Creator: U.S. Food and Drug Administration
Published: 1987-08-27

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K872537 for PROTHROMBIN TIME TEST, Substantially Equivalent on 1987-08-27. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1987-06-25
Decision date: 1987-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GJS

view all

K253188 — CoaguChek XS Plus System2025-10-24
K251564 — microINR System2025-07-21
K243543 — microINR System2025-02-27
K230802 — Xprecia Prime Coagulation System2024-03-15
K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System2023-07-14

More clearances from Sclavo, Inc.

view all

K914789 — ELISA CMV IGM1992-03-04
K914852 — ELISA TOXO IGM1992-01-23
K914420 — ELISA RUBELLA IGM1991-12-27
K895943 — NORMAL AND ABNORMAL CONTROL SERA1989-12-27
K895822 — TOTAL BILIRUBIN L.F.1989-11-14

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.