510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931666Substantially Equivalent

Quantikine(tm) Erythropoietin/enz Link Immun Assay

R & D Systems, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931666 is the FDA 510(k) clearance record for QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY, a class II device, cleared for R&D Systems, Inc. on under FDA product code GGT (Assay, Erythropoietin). FDA records list 79 510(k) clearances for R&D Systems, Inc., from to . As of , FDA records show no recalls naming K931666.

Clearance record

Decision date
Received
(105 days to decision)
Product code
GGT Assay, Erythropoietin
Regulation
21 CFR 864.7250
Device class
Class II
Review panel
Hematology
Applicant
R&D Systems, Inc. 614 Mckinley Pl. NE, Minneapolis MN
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