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510(k) K922934

ENZYGNOST F 1+2 by Behring Diagnostics, Inc. — Product Code MIF

K922934 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "ENZYGNOST F 1+2". The FDA issued a decision of Substantially Equivalent on November 16, 1992. The device falls under product code MIF (Prothrombin Fragment 1.2), a Class II device regulated under 21 CFR 864.7320. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1992
Date Received
June 18, 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 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)

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)
  • K920895 — DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA (June 4, 1992)
  • K911434 — THROMBONOSTIKA F1.2 (October 31, 1991)

FDA data resources