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510(k) K810011

GAMMA STICK 125-1 TOBRAMYCIN RIA KIT by Alpha Gamma Laboratory — Product Code KLB

K810011 is an FDA 510(k) premarket notification submitted by Alpha Gamma Laboratory for the device "GAMMA STICK 125-1 TOBRAMYCIN RIA KIT". The FDA issued a decision of Substantially Equivalent on January 28, 1981. The device falls under product code KLB (Radioimmunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Alpha Gamma Laboratory has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1981
Date Received
January 5, 1981
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 Alpha Gamma Laboratory

  • K800537 — GAMMA STICK GENTAMICIN RIA KIT (April 24, 1980)
  • K800538 — GAMMA STICK CORTISOL RIA KIT/STICK KIT (April 24, 1980)
  • K780492 — GAMMA STIK 125I T3 UPTAKE KIT (April 28, 1978)

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)

FDA data resources