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510(k) K003341

EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS by Syva Co., Dade Behring, Inc. — Product Code KLB

K003341 is an FDA 510(k) premarket notification submitted by Syva Co., Dade Behring, Inc. for the device "EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on January 22, 2001. The device falls under product code KLB (Radioimmunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Syva Co., Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2001
Date Received
October 25, 2000
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 Syva Co., Dade Behring, Inc.

  • K011920 — EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (July 2, 2001)
  • K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 (June 18, 2001)
  • K011605 — EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 (June 12, 2001)
  • K011300 — EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 (May 17, 2001)
  • K011306 — EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 (May 16, 2001)
  • K011161 — MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 (May 15, 2001)
  • K011289 — EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 (May 15, 2001)
  • K011163 — MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (May 10, 2001)
  • K011166 — MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (May 10, 2001)
  • K011164 — MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 (May 10, 2001)

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)
  • 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)
  • K832763 — TOBRAMYCIN REAGENT (March 23, 1984)

FDA data resources