Home / 510(k) Clearances / K910105

510(k) K910105

PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 by International Technidyne Corp. — Product Code GFT

K910105 is an FDA 510(k) premarket notification submitted by International Technidyne Corp. for the device "PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200". The FDA issued a decision of Substantially Equivalent on February 26, 1991. The device falls under product code GFT (Protamine Sulphate), a Class II device regulated under 21 CFR 864.7525. International Technidyne Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1991
Date Received
January 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protamine Sulphate
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

Other clearances by International Technidyne Corp.

  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • K050016 — HEMOCHRON SIGNATURE ELITE (February 10, 2005)
  • K030818 — HEMOCHRON RESPONSE/SYSTEM (April 2, 2003)
  • K023561 — ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM (January 31, 2003)
  • K020798 — HEMOCHRON JR. SIGNATURE + (March 28, 2002)
  • K010599 — PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE (July 2, 2001)
  • K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (June 6, 2001)
  • K983475 — HEMOCHRON RESPONSE (May 3, 1999)
  • K990449 — HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE (April 13, 1999)
  • K972866 — HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT (September 30, 1998)

Other clearances for product code GFT

  • K944115 — HEPARIN ASSAY CARTRIDGES AND CONTROLS (March 24, 1995)

FDA data resources