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510(k) K780949

BIO-MONITOR AMIKACIN by Monitor Science Corp. — Product Code KLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
June 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amikacin Serum Assay
Device Class
Class II
Regulation Number
862.3035
Review Panel
TX
Submission Type

Other clearances by Monitor Science Corp.

  • K790580 — RIA KIT, PROSTATIC ACID (May 25, 1979)
  • K780950 — BIO-MONITOR TOBRAMYCIN (August 14, 1978)
  • K780951 — BIO-MONITOR GENTAMICIN (August 14, 1978)
  • K772038 — KANAMYCIN RIA (January 12, 1978)
  • K772039 — BETA-HCG RIA (November 23, 1977)

Other clearances for product code KLP

  • K032279 — ONLINE TDM AMIKA (October 10, 2003)
  • K873426 — EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 (October 29, 1987)
  • K790899 — BACTEC (May 23, 1979)