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510(k) K812829

COATEST ANTITHROMBIN by Kabivitrum, Inc. — Product Code JBQ

K812829 is an FDA 510(k) premarket notification submitted by Kabivitrum, Inc. for the device "COATEST ANTITHROMBIN". The FDA issued a decision of Substantially Equivalent on December 30, 1981. The device falls under product code JBQ (Antithrombin Iii Quantitation), a Class II device regulated under 21 CFR 864.7060. Kabivitrum, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1981
Date Received
October 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antithrombin Iii Quantitation
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type

Other clearances by Kabivitrum, Inc.

  • K884058 — COATEST PROTEIN C (December 13, 1988)
  • K854572 — COATEST PLASMINOGEN (February 26, 1986)
  • K844664 — THE I.V. BAG (May 6, 1985)
  • K833890 — COATEST ANTIPLASMIN (January 30, 1984)
  • K833891 — COATEST HEPARIN (January 30, 1984)
  • K833892 — COATEST FACTOR VIII (January 30, 1984)
  • K832114 — COATEST FACTOR X (August 26, 1983)

Other clearances for product code JBQ

  • K242952 — INNOVANCE Antithrombin (March 28, 2025)
  • K081769 — INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (May 28, 2009)
  • K070301 — HEMOSIL ANTITHROMBIN (February 23, 2007)
  • K062431 — HEMOSIL LIQUID ANTITHROMBIN (September 1, 2006)
  • K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE (November 7, 2005)
  • K033775 — HEMOSIL LIQUID ANTITHROMBIN XL (January 2, 2004)
  • K023991 — CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (April 28, 2003)
  • K022550 — COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (August 27, 2002)
  • K022195 — COAMATIC AT-400 (August 7, 2002)
  • K994238 — IL TEST LIQUID ANTITHROMBIN (June 23, 2000)

FDA data resources