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510(k) K821543

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

K821543 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics Laboratories, Inc. for the device "IPA FOR DETECTION OF PHENOBARBITAL". The FDA issued a decision of Substantially Equivalent on June 3, 1982. The device falls under product code LFN (Nephelometric Inhibition Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Electro-Nucleonics Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K873925 — VIRGO(TM) MEASLES IGG ELISA (February 24, 1988)
  • K873617 — GEMSTAR II SYSTEM (October 19, 1987)
  • K873416 — MULTI-ACCESS REAGENT DISPENSER (October 9, 1987)
  • 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)
  • K860304 — DUPONT PHENOBARBITAL ASSAY (February 28, 1986)
  • K860303 — DUPONT PHENOBARBITAL CALIBRATOR (February 28, 1986)

FDA data resources