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510(k) K980737

ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY by Nichols Institute Diagnostics — Product Code GGT

K980737 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on March 23, 1999. The device falls under product code GGT (Assay, Erythropoietin), a Class II device regulated under 21 CFR 864.7250. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1999
Date Received
February 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Erythropoietin
Device Class
Class II
Regulation Number
864.7250
Review Panel
HE
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 GGT

  • K240182 — Access EPO (April 22, 2024)
  • K183088 — ADVIA Centaur Erythropoietin (EPO) assay (August 2, 2019)
  • K052223 — ACCESS EPO ASSAY (October 6, 2006)
  • K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (June 7, 2000)
  • K983203 — IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 (July 12, 1999)
  • K952559 — ERYTHROPOIETIN IMMUNOASSAY KIT (May 29, 1996)
  • K954898 — PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (February 5, 1996)
  • K936016 — QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (July 19, 1994)
  • K931756 — QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS (April 21, 1994)
  • K932650 — ERYTHROPOIETIN IMMUNOASSAY KIT (March 11, 1994)

FDA data resources