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510(k) K992188

NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 by Nichols Institute Diagnostics — Product Code JNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1999
Date Received
June 29, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunochemical, Transferrin
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
Submission Type

Other clearances by Nichols Institute Diagnostics

  • K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (June 1, 2005)
  • 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 JNM

  • K981208 — TFR (October 21, 1998)
  • K970718 — QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (May 27, 1997)