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510(k) K902530

SPECTROLYSE ATIII KIT by Biopool AB — Product Code JBQ

K902530 is an FDA 510(k) premarket notification submitted by Biopool AB for the device "SPECTROLYSE ATIII KIT". The FDA issued a decision of Substantially Equivalent on August 9, 1990. The device falls under product code JBQ (Antithrombin Iii Quantitation), a Class II device regulated under 21 CFR 864.7060. Biopool AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1990
Date Received
June 5, 1990
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 Biopool AB

  • K941752 — SPECTROLYSE ANTIPLASMIN KIT (September 25, 1995)
  • K942087 — BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES (July 13, 1995)
  • K934314 — TINTELIZER(R) TPA (February 23, 1994)
  • K923499 — SPECTROLYSE HEPARIN KIT (January 27, 1994)
  • K932463 — BIOCLOT LA (September 27, 1993)
  • K920668 — MINUTEX D-DIMER LATEX TEST (October 16, 1992)
  • K922782 — SPECTROLYSE/PL PAI KIT (October 9, 1992)
  • K915163 — PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES (January 6, 1992)
  • K914307 — SPECTROLYSE PROTEIN C KIT (December 9, 1991)
  • K912025 — SPECTROLYSE PLASMINOGEN SK KIT (August 22, 1991)

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