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510(k) K813516

MRI TOBRAMYCIN RIA KIT by Microanalytic Research, Inc. — Product Code KLB

K813516 is an FDA 510(k) premarket notification submitted by Microanalytic Research, Inc. for the device "MRI TOBRAMYCIN RIA KIT". The FDA issued a decision of Substantially Equivalent on December 29, 1981. The device falls under product code KLB (Radioimmunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Microanalytic Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1981
Date Received
December 15, 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 Microanalytic Research, Inc.

  • K861097 — TRYPSIN RIA KIT (May 29, 1986)
  • K820741 — MR1 LUTROPIN RIA KIT (April 14, 1982)
  • K820740 — MR1 FOLLITROPIN RIA KIT (April 6, 1982)
  • K812394 — MRI GENTAMICIN RIA KIT (September 8, 1981)
  • K810949 — MRI PROLACTIN RIA KIT (July 10, 1981)
  • K802754 — IMMUNOREACTIVE ESTRIOL RIA KIT (January 21, 1981)
  • K801491 — MRI HCG-BETA RIA KIT CAT. #MR-10100 (August 13, 1980)

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