Home / 510(k) Clearances / K903034

510(k) K903034

RENALYZER PRX 90 by Swedish Trade Council USA — Product Code CGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1991
Date Received
July 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Based, Enzymatic, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Swedish Trade Council USA

  • K894490 — STERILE ULTRASOUND TRANSMISSION GEL (October 5, 1989)

Other clearances for product code CGL

  • K171059 — Nova StatSensor Creatinine Hospital Meter System (May 26, 2017)
  • K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TEST (October 5, 2012)
  • K070068 — NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS (May 7, 2007)
  • K051968 — ABL8X7 FLEX (October 16, 2006)
  • K991727 — STAT PROFILE M7 ANALYZER (July 16, 1999)
  • K973292 — I-STAT SYSTEM (October 20, 1997)