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510(k) K892209

APTT BY HEMOCHRON(R) by Intensive Technology, Inc. — Product Code GFO

K892209 is an FDA 510(k) premarket notification submitted by Intensive Technology, Inc. for the device "APTT BY HEMOCHRON(R)". The FDA issued a decision of Substantially Equivalent on June 22, 1989. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Intensive Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
April 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

Other clearances by Intensive Technology, Inc.

  • K922970 — INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM (January 13, 1993)
  • K912664 — TEC ROTATING DUAL HEMOVALVE (August 24, 1992)
  • K911869 — IVT GUIDING CATHETER (October 16, 1991)
  • K903463 — IVT INTRODUCER SHEATH (January 3, 1991)
  • K904003 — HEMOCHRON(R) HEPARIN RESPONSE TEST (November 29, 1990)
  • K901767 — MODIFIED IVT PERIPHERAL ATHERECTOMY (June 28, 1990)
  • K896403 — MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM (March 6, 1990)
  • K895903 — IVT 0.014 GUIDE WIRE (January 4, 1990)
  • K890515 — PERIPHERAL ATHERECTOMY SYSTEM (May 23, 1989)
  • K882804 — 0.014 PERIPHERAL GUIDE WIRE (October 28, 1988)

Other clearances for product code GFO

  • K253957 — HemosIL Silica Clotting Time (January 9, 2026)
  • K193556 — Cryocheck Hex LA (October 23, 2020)
  • K160445 — HemosIL Silica Clotting Time (March 16, 2016)
  • K053111 — STA-CEPHASCREEN KIT (May 4, 2006)
  • K060688 — HEMOSIL SYNTHASIL (April 13, 2006)
  • K050221 — HEMOSIL SILICA CLOTTING TIME (March 30, 2005)
  • K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (November 1, 2002)
  • K014028 — CARESIDE APTT (February 8, 2002)
  • K014008 — HEMOCHRON JR. CITRATE APTT CUVETTE (January 24, 2002)
  • K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (December 6, 1999)

FDA data resources