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510(k) K821543

IPA FOR DETECTION OF PHENOBARBITAL by Electro-Nucleonics Laboratories, Inc. — Product Code LFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1982
Date Received
May 24, 1982
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 Electro-Nucleonics Laboratories, Inc.

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  • K873358 — GEMENI URIC ACID U.V. (September 11, 1987)
  • K873088 — VIRGO(TM) RUBELLA IGG ELISA (September 9, 1987)
  • K871905 — TOXOPLASMA GONDII IGG ELISA (July 30, 1987)
  • K870928 — CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS (April 22, 1987)
  • K863874 — LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES (November 13, 1986)
  • K862640 — AMYLASE LTS (September 9, 1986)
  • K853372 — GEMSTAR IPA THEOPHYLLINE TEST KIT (September 4, 1985)

Other clearances for product code LFN

  • K934388 — QMS PHENOBARBITAL (February 25, 1994)
  • K864612 — DART PHENOBARBITAL ASSAY SYSTEM (January 13, 1987)
  • K860303 — DUPONT PHENOBARBITAL CALIBRATOR (February 28, 1986)
  • K860304 — DUPONT PHENOBARBITAL ASSAY (February 28, 1986)