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510(k) K832763

TOBRAMYCIN REAGENT by Biosan Laboratories, Inc. — Product Code KLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
August 16, 1983
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

Other clearances by Biosan Laboratories, Inc.

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  • K833193 — RADIOIMMUNOASSAY, THYROID STIMU. HORMONE (February 4, 1984)
  • K834023 — BIO-SCIENCE LABORATORIES T4 REAGENT (January 24, 1984)
  • K833318 — NORMAL GOAT SERUM (January 3, 1984)
  • K833320 — AMBERLITE CG50 RESIN, 100-200 MESH (December 8, 1983)
  • K833192 — NORMAL URINE CONTROL (December 8, 1983)
  • K833191 — ABNORMAL URINE CONTROL (December 8, 1983)
  • K833319 — BIO-REX 70 RESIN 100-200 MESH PH6.2 (November 3, 1983)

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)
  • K852671 — ACA TOBRAMY-CIN ANALYTICAL TEST PACK (July 22, 1985)