Home / 510(k) Clearances / K780950

510(k) K780950

BIO-MONITOR TOBRAMYCIN by Monitor Science Corp. — Product Code DID

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
Bacillus Subtilis Microbiology Assay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
Review Panel
TX
Submission Type

Other clearances by Monitor Science Corp.

  • K790580 — RIA KIT, PROSTATIC ACID (May 25, 1979)
  • K780949 — BIO-MONITOR AMIKACIN (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 DID

  • K820773 — EMIT-ST URINE COCAINE METABOLITE ASSAY (April 8, 1982)
  • K802038 — PHENYTOIN REAGENT TEST KIT (October 23, 1980)
  • K780182 — TOBRAMYCIN 125I RIA KIT (February 13, 1978)
  • K780048 — AMINOGLYCOSIDE TEST SYSTEM (January 20, 1978)