TE-25 COAGURO METER— 510(k) K854686

Substantially Equivalent

Future Impex Corp.

FDA 510(k) clearance K854686 for TE-25 COAGURO METER, Substantially Equivalent on 1986-06-04. Applicant: Future Impex Corp.. Device class: 2.

Clearance details

Applicant: Future Impex Corp.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1985-11-20
Decision date: 1986-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerpark, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JBP

K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer2023-01-04
K062604 — RAPIDTEG TEG-ACT TEST2007-01-31
K032952 — AIACT KIT2003-12-12
K023582 — I-STAT KAOLIN ACT TEST2003-09-08
K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 57702002-05-23

More clearances from Future Impex Corp.

K861487 — ST-90 SPIRO ANALIZER1986-06-23
K854687 — ERMA HB-METER MODEL 303N1986-06-04
K854685 — DIGITAL-9 KEY LEUCOCYTE COUNTER1986-04-04
K854677 — ERMA PC-604 BLOOD CELL COUNTER1986-02-24
K854678 — ERMA PC-602 PC-603 BLOOD CELL COUNTER1986-02-24

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