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510(k) K934003

STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY by Baxter Diagnostics, Inc. — Product Code DKA

K934003 is an FDA 510(k) premarket notification submitted by Baxter Diagnostics, Inc. for the device "STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code DKA (Antiserum, Digoxin), a Class II device regulated under 21 CFR 862.3320. 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
August 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Digoxin
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
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 DKA

  • K780498 — CBR-DIGOXIN ANTISERUM (April 5, 1978)
  • K780316 — RABBIT ANTIBODY TO DIGOXIN (March 17, 1978)

FDA data resources