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510(k) K852671

ACA TOBRAMY-CIN ANALYTICAL TEST PACK by E.I. Dupont DE Nemours & Co., Inc. — Product Code KLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1985
Date Received
June 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
Review Panel
TX
Submission Type

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  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)
  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)

Other clearances for product code KLB

  • K060853 — ONLINE TDM TOBRAMYCIN (June 9, 2006)
  • K012312 — IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) (August 20, 2001)
  • K003341 — EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS (January 22, 2001)
  • K904304 — DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD (October 26, 1990)
  • K903192 — IL TOBRAMYCIN ASSAY (August 22, 1990)
  • K893913 — TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD (August 21, 1989)
  • K882294 — EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY (July 1, 1988)
  • K874223 — EMIT TOBRAMYCIN ASSAY (November 13, 1987)
  • K854184 — IN-VITRO TEST DETERMINATION OF TOBRAMYCIN (December 4, 1985)
  • K832763 — TOBRAMYCIN REAGENT (March 23, 1984)