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510(k) K780048

AMINOGLYCOSIDE TEST SYSTEM by Nichols Institute Diagnostics — Product Code DID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1978
Date Received
January 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 Nichols Institute Diagnostics

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  • K042676 — NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY (December 17, 2004)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)
  • K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 (June 8, 2004)
  • K033727 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY (April 22, 2004)
  • K033302 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 (January 26, 2004)
  • K032188 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (July 31, 2003)
  • K022356 — NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASS (October 25, 2002)
  • K022472 — PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTAC (October 9, 2002)
  • K013992 — NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNO (December 13, 2001)

Other clearances for product code DID

  • K820773 — EMIT-ST URINE COCAINE METABOLITE ASSAY (April 8, 1982)
  • K802038 — PHENYTOIN REAGENT TEST KIT (October 23, 1980)
  • K780950 — BIO-MONITOR TOBRAMYCIN (August 14, 1978)
  • K780182 — TOBRAMYCIN 125I RIA KIT (February 13, 1978)