510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171650Substantially Equivalent

Alere Afinion HbA1c and ACR on Afinion 2 analyzer

Abbott Rapid Diagnostics, San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171650 is the FDA 510(k) clearance record for Alere Afinion HbA1c and ACR on Afinion 2 analyzer, a class II device, cleared for Abbott Rapid Diagnostics on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list one 510(k) clearance for Abbott Rapid Diagnostics. As of , FDA records show 2 recalls naming K171650.

Clearance record

Decision date
Received
(169 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Abbott Rapid Diagnostics 9975 Summers Ridge Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

FDA records show no clearances under product code LCP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCP, 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