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510(k) K981752

I-STAT COAGULATION CONTROL SET by Biopool Intl., Inc. — Product Code GGN

K981752 is an FDA 510(k) premarket notification submitted by Biopool Intl., Inc. for the device "I-STAT COAGULATION CONTROL SET". The FDA issued a decision of Substantially Equivalent on June 15, 1998. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Biopool Intl., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1998
Date Received
May 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Biopool Intl., Inc.

  • K002642 — MINIQUANT D-DIMER, MODEL 1447 (February 5, 2001)
  • K983898 — BIOCLOT APC SENSITIVITY (January 6, 1999)
  • K980314 — FETAL D TECTION KIT (April 8, 1998)

Other clearances for product code GGN

  • K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (June 21, 2017)
  • K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit (March 16, 2017)
  • K161316 — George King Coumadin Plasma (February 23, 2017)
  • K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (January 5, 2017)
  • K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (June 3, 2016)
  • K150144 — VisuCon-F Low Fibrinogen Control Plasma (March 6, 2016)
  • K142132 — POOL NORM (December 12, 2014)
  • K133582 — HEMOSIL D-DIMER HS 500 CONTROL (August 15, 2014)
  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)

FDA data resources