510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980737Substantially Equivalent

Advantage Chemiluminescence Erythropoietin Immunoassay

Nichols Institute Diagnostics, San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980737 is the FDA 510(k) clearance record for ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY, a class II device, cleared for Nichols Institute Diagnostics on under FDA product code GGT (Assay, Erythropoietin). FDA records list 68 510(k) clearances for Nichols Institute Diagnostics, from to . As of , FDA records show no recalls naming K980737.

Clearance record

Decision date
Received
(391 days to decision)
Product code
GGT Assay, Erythropoietin
Regulation
21 CFR 864.7250
Device class
Class II
Review panel
Hematology
Applicant
Nichols Institute Diagnostics 33051 Calle Aviador, San Juan Capistrano CA
510(k) summary
Summary
Third party review
No

Clearances, product code GGT

Trailing 12 months

FDA records hold no clearances under product code GGT in the trailing twelve months.

FDA records show no clearances under product code GGT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GGT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260