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510(k) K955448

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS by Behring Diagnostics, Inc. — Product Code DLB

K955448 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS". The FDA issued a decision of Substantially Equivalent on February 23, 1996. The device falls under product code DLB (Radioimmunoassay, Lsd (125-I)), a Class II device regulated under 21 CFR 862.3580. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1996
Date Received
November 29, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Lsd (125-I)
Device Class
Class II
Regulation Number
862.3580
Review Panel
TX
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 DLB

  • K961436 — ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) (June 21, 1996)
  • K955814 — CEDIA DAU LSD ASSAY (February 9, 1996)
  • K954073 — STC DIAGNOSTICS LSD MICRO-PLATE EIA (November 29, 1995)
  • K891167 — COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT (May 3, 1989)
  • K874270 — REVISED LABELING FOR LSD TEST KIT (November 13, 1987)
  • K860525 — ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD (April 11, 1986)

FDA data resources