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510(k) K920895

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA by Baxter Diagnostics, Inc. — Product Code MIF

K920895 is an FDA 510(k) premarket notification submitted by Baxter Diagnostics, Inc. for the device "DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA". The FDA issued a decision of Substantially Equivalent on June 4, 1992. The device falls under product code MIF (Prothrombin Fragment 1.2), a Class II device regulated under 21 CFR 864.7320. Baxter Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1992
Date Received
February 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prothrombin Fragment 1.2
Device Class
Class II
Regulation Number
864.7320
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 MIF

  • K042687 — ENZYGNOST F+2 (MONOCLONAL) TEST KIT (December 10, 2004)
  • K964934 — THROMBONOSTIKA F1.2 (March 18, 1997)
  • K962176 — TPP (October 18, 1996)
  • K922934 — ENZYGNOST F 1+2 (November 16, 1992)
  • K911434 — THROMBONOSTIKA F1.2 (October 31, 1991)

FDA data resources