Home / 510(k) Clearances / K123805

510(k) K123805

E-Z CHEK BLOOD LEAK TEST STRIPS by Reprocessing Products Corp — Product Code FJD

K123805 is an FDA 510(k) premarket notification submitted by Reprocessing Products Corp for the device "E-Z CHEK BLOOD LEAK TEST STRIPS". The FDA issued a decision of Substantially Equivalent on March 20, 2013. The device falls under product code FJD (Detector, Leak, Blood), a Class II device regulated under 21 CFR 876.5820. Reprocessing Products Corp has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2013
Date Received
December 11, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Leak, Blood
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Reprocessing Products Corp

  • K101750 — RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST S (January 7, 2011)
  • K090338 — ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE (May 8, 2009)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974064 — MICRO X RESIDUAL TEST STRIPS (December 7, 1998)
  • K950602 — PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS (November 30, 1995)

Other clearances for product code FJD

  • K042322 — STERICHEK BLOOD LEAK REAGENT STRIPS (December 7, 2004)
  • K012115 — SERIM BLOOD LEAK TEST STRIP-2 (November 30, 2001)
  • K990206 — SERIM BLOOD LEAK TEST STRIP (April 21, 1999)

FDA data resources