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510(k) K864612

DART PHENOBARBITAL ASSAY SYSTEM by Coulter Electronics, Inc. — Product Code LFN

K864612 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "DART PHENOBARBITAL ASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 13, 1987. The device falls under product code LFN (Nephelometric Inhibition Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1987
Date Received
November 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometric Inhibition Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

Other clearances by Coulter Electronics, Inc.

  • K923951 — CD8 CYTOSPHERES KIT (April 25, 1994)
  • K930119 — COULTER RETIC-C CELL CONTROL (April 5, 1993)
  • K921279 — CD4 CYTOSPHERES KIT (December 29, 1992)
  • K923530 — COULTER MULTI-Q-PREP (October 14, 1992)
  • K922181 — COULTER MH009 (August 17, 1992)
  • K922704 — COULTER MAXM W/ AUTOLOADER (July 27, 1992)
  • K921567 — COULTER MH017 (July 6, 1992)
  • K912133 — PX COULTER(R) CELL CONTROL (July 17, 1991)
  • K911385 — COULTER(R) MH010 (June 17, 1991)
  • K905771 — COULTER DART AST (GOT) REAGENT (February 26, 1991)

Other clearances for product code LFN

  • K934388 — QMS PHENOBARBITAL (February 25, 1994)
  • K860304 — DUPONT PHENOBARBITAL ASSAY (February 28, 1986)
  • K860303 — DUPONT PHENOBARBITAL CALIBRATOR (February 28, 1986)
  • K821543 — IPA FOR DETECTION OF PHENOBARBITAL (June 3, 1982)

FDA data resources