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510(k) K932650

ERYTHROPOIETIN IMMUNOASSAY KIT by Nichols Institute — Product Code GGT

K932650 is an FDA 510(k) premarket notification submitted by Nichols Institute for the device "ERYTHROPOIETIN IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on March 11, 1994. The device falls under product code GGT (Assay, Erythropoietin), a Class II device regulated under 21 CFR 864.7250. Nichols Institute has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
June 2, 1993
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

  • K952559 — ERYTHROPOIETIN IMMUNOASSAY KIT (May 29, 1996)
  • K952505 — INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) (July 3, 1995)
  • K946247 — IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 (June 23, 1995)
  • K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (May 15, 1995)
  • K931600 — CHEMILUMINESCENCE FREE T3 IMMUNOASSAY (September 8, 1993)
  • K931777 — APO A-1 CHEMILUMINESCENCE ASSAY (August 16, 1993)
  • K926396 — ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT (July 27, 1993)
  • K931601 — CHEMILUMINESCENCE DHEA-S IMMUNOASSAY (July 27, 1993)
  • K931311 — THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT (May 14, 1993)
  • K930777 — THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT (April 8, 1993)

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)
  • K980737 — ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY (March 23, 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)

FDA data resources