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510(k) K951012

N/T PROTEIN CONTROL PY by Behring Diagnostics, Inc. — Product Code GIL

K951012 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "N/T PROTEIN CONTROL PY". The FDA issued a decision of Substantially Equivalent on April 17, 1995. The device falls under product code GIL (Plasma, Fibrinogen Control), a Class II device regulated under 21 CFR 864.7340. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1995
Date Received
March 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Fibrinogen Control
Device Class
Class II
Regulation Number
864.7340
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 GIL

  • K962407 — N/T PROTEIN CONTROL PY (July 29, 1996)
  • K946193 — FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 (August 24, 1995)
  • K946265 — FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (August 24, 1995)
  • K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (May 2, 1995)
  • K934741 — LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 (September 8, 1994)
  • K915462 — FIBRINOGEN CONTROL (March 4, 1992)
  • K833352 — GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL (November 3, 1983)

FDA data resources