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510(k) K770942

PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY by Pharmaseal Div., Baxter Healthcare Corp. — Product Code JBQ

K770942 is an FDA 510(k) premarket notification submitted by Pharmaseal Div., Baxter Healthcare Corp. for the device "PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY". The FDA issued a decision of Substantially Equivalent on July 21, 1977. The device falls under product code JBQ (Antithrombin Iii Quantitation), a Class II device regulated under 21 CFR 864.7060. Pharmaseal Div., Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1977
Date Received
May 24, 1977
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 Pharmaseal Div., Baxter Healthcare Corp.

  • K792369 — HYPERALIMENTATION DRESSING TRAY (December 10, 1979)
  • K792141 — CONTINUOUS FLUSH DEVICE (December 5, 1979)
  • K792019 — PHADECODE XA INHIBITOR ASSAY (November 5, 1979)
  • K791773 — VENTILATOR TUBE WITH FILTER (October 22, 1979)
  • K791156 — AMIPAQUE MYELOGRAM TRAY (July 30, 1979)
  • K790896 — TWO-WAY ANESTHESIA FILTER (June 5, 1979)
  • K790409 — LOW DEAD SPACE INSULIN SYRINGE (April 24, 1979)
  • K782069 — TRAY, AUXILLARY BLOCK (January 4, 1979)
  • K781797 — PREP TRAY, PREOPERATIVE SKIN (November 8, 1978)
  • K781680 — MONITORING, PRESSURE KIT (October 6, 1978)

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