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510(k) K925452

DADE HEPZYME by Baxter Diagnostics, Inc. — Product Code JBR

K925452 is an FDA 510(k) premarket notification submitted by Baxter Diagnostics, Inc. for the device "DADE HEPZYME". The FDA issued a decision of Substantially Equivalent on January 11, 1993. The device falls under product code JBR (Test, Heparin Neutralization), a Class II device regulated under 21 CFR 864.7525. Baxter Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1993
Date Received
October 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Heparin Neutralization
Device Class
Class II
Regulation Number
864.7525
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 JBR

  • K874373 — PT PRO-CLOT (January 5, 1988)
  • K770722 — THROMBO SCREEN QUANTITATIVE HEPARIN ASSA (July 11, 1977)

FDA data resources