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510(k) K955814

CEDIA DAU LSD ASSAY by Microgenics Corp. — Product Code DLB

K955814 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "CEDIA DAU LSD ASSAY". The FDA issued a decision of Substantially Equivalent on February 9, 1996. The device falls under product code DLB (Radioimmunoassay, Lsd (125-I)), a Class II device regulated under 21 CFR 862.3580. Microgenics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1996
Date Received
December 26, 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 Microgenics Corp.

  • K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY (August 20, 2013)
  • K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (July 11, 2013)
  • K123271 — ABBOTT PHENOBARBITAL ASSAY (April 26, 2013)
  • K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO (June 29, 2011)
  • K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (April 8, 2011)
  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)
  • K101753 — THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY (April 8, 2011)
  • K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (April 8, 2011)
  • K101744 — THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY (April 8, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)

Other clearances for product code DLB

  • K961436 — ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) (June 21, 1996)
  • K955448 — EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS (February 23, 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