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510(k) K821542

VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA by Electro-Nucleonics Laboratories, Inc. — Product Code LCR

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
Fluorescent Immunoassay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
Review Panel
TX
Submission Type

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  • K853372 — GEMSTAR IPA THEOPHYLLINE TEST KIT (September 4, 1985)

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  • K911940 — OPUS(R) TOBRAMYCIN (July 1, 1991)
  • K911613 — VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (June 28, 1991)
  • K854873 — INTRAOCULAR PRESSURE REDUCER (February 4, 1986)
  • K850058 — DU PONT TOBRAMYCIN ASSAY REAGENTS (January 18, 1985)
  • K840847 — IMMPULSE TOBRAMYCIN ASSAY REAGENTS (April 4, 1984)
  • K832408 — STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM (August 26, 1983)