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510(k) K935307

DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA by Baxter Diagnostics, Inc. — Product Code DDQ

K935307 is an FDA 510(k) premarket notification submitted by Baxter Diagnostics, Inc. for the device "DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code DDQ (Antigen, Antiserum, Control, Antithrombin Iii), a Class II device regulated under 21 CFR 864.7060. Baxter Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
November 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Antiserum, Control, Antithrombin Iii
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type

Other clearances by Baxter Diagnostics, Inc.

  • K934458 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (July 18, 1995)
  • K950817 — DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI (April 25, 1995)
  • K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS (April 14, 1995)
  • K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (April 11, 1995)
  • K945235 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (March 7, 1995)
  • K941030 — DRIED GRAM-NEGATIVE CEFPODOXIME (February 16, 1995)
  • K940917 — LORACARBEF GRAM-NAGATIVE PANELS (February 8, 1995)
  • K941459 — GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX (February 3, 1995)
  • K941317 — DRIED GRAM NEGATIVE/CEFMETAZOLE (January 31, 1995)
  • K942089 — MICRODILUTION/LORACARBEF PANELS (January 9, 1995)

Other clearances for product code DDQ

  • K972257 — N-ASSAY TIA ANTITHROMBIN III TEST KIT (October 20, 1997)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K780012 — ANTITHROMBIN III RIA (January 20, 1978)

FDA data resources