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510(k) K800517

TOBRAM E.R.A. TM by P-L Biochemicals, Inc. — Product Code KLQ

K800517 is an FDA 510(k) premarket notification submitted by P-L Biochemicals, Inc. for the device "TOBRAM E.R.A. TM". The FDA issued a decision of Substantially Equivalent on March 20, 1980. The device falls under product code KLQ (Radioimmunoassay, Amikacin), a Class II device regulated under 21 CFR 862.3035. P-L Biochemicals, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1980
Date Received
March 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Amikacin
Device Class
Class II
Regulation Number
862.3035
Review Panel
TX
Submission Type

Other clearances by P-L Biochemicals, Inc.

  • K813449 — PHE/TYR KINETIC UV TEST SET (December 31, 1981)

Other clearances for product code KLQ

  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K033884 — RANDOX AMIKACIN (June 9, 2004)
  • K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEM (February 9, 1996)
  • K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SET (August 9, 1990)
  • K894517 — FPR AMIKACIN KIT (September 28, 1989)
  • K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR (June 25, 1985)
  • K843211 — AMIKACIN ANALYTICAL TEST PACK ACA (September 12, 1984)
  • K841161 — IMMPULSE AMIKACIN ASSAY REAGENTS (May 2, 1984)
  • K840193 — EMIT QST AMIKACIN ASSAY (March 23, 1984)
  • K832336 — STRATUS AMIKACIN FLUOROMETRIC (August 31, 1983)

FDA data resources