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510(k) K792259

AMIKACIN CONTROL SERUM by Hemometrix — Product Code LAS

K792259 is an FDA 510(k) premarket notification submitted by Hemometrix for the device "AMIKACIN CONTROL SERUM". The FDA issued a decision of Substantially Equivalent on December 18, 1979. The device falls under product code LAS (Drug Specific Control Materials), a Class I device regulated under 21 CFR 862.3280. Hemometrix has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1979
Date Received
November 9, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Hemometrix

  • K800037 — PLATELET RETENTION (ADHESION) COLUMNS (February 5, 1980)
  • K792261 — GENTAMICIN CONTROL SERUM (December 18, 1979)
  • K792262 — GENTAMICIN LIQUID CONTROL SERUM (December 18, 1979)
  • K792263 — TOBRAMYCIN CONTROL SERUM (December 18, 1979)
  • K792260 — AMIKACIN LIQUID CONTROL SERUM (December 18, 1979)
  • K792264 — TOBRAMYCIN LIQUID CONTROL SERUM (December 18, 1979)

Other clearances for product code LAS

  • K080459 — CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (November 17, 2009)
  • K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (January 30, 2008)
  • K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL (October 30, 2006)
  • K051074 — MAS IMMUNOSUPPRESSANT CONTROLS (June 6, 2005)
  • K040411 — DRI OXYCODONE ASSAY (May 27, 2004)
  • K032842 — MICROGENICS CYCLOSPORINE CONTROL KIT (October 17, 2003)
  • K030616 — CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (March 31, 2003)
  • K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (July 14, 1999)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K971210 — SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (April 17, 1997)

FDA data resources