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510(k) K880294

DART PHENYTOIN by Coulter Electronics, Inc. — Product Code LFO

K880294 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "DART PHENYTOIN". The FDA issued a decision of Substantially Equivalent on May 27, 1988. The device falls under product code LFO (Nephelometric Inhibition Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1988
Date Received
January 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometric Inhibition Immunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
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)

FDA data resources