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510(k) K933125

BERICHROM ANTITHROMBIN III (A) by Behring Diagnostics, Inc. — Product Code JPE

K933125 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "BERICHROM ANTITHROMBIN III (A)". The FDA issued a decision of Substantially Equivalent on April 19, 1994. The device falls under product code JPE (Antithrombin Iii, Two Stage Clotting Time Assay), a Class II device regulated under 21 CFR 864.7060. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1994
Date Received
June 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antithrombin Iii, Two Stage Clotting Time Assay
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type

Other clearances by Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

FDA data resources