510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083223Substantially Equivalent

Relion Ultima Blood Glucose Monitoring System, Models 70055-50, Strips (20 Count): 70973-01

Abbott Medical, Alameda CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083223 is the FDA 510(k) clearance record for RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01, a class II device, cleared for Abbott Diabetes Care, Inc. on under FDA product code LFR (Glucose Dehydrogenase, Glucose). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show one recall naming K083223.

Clearance record

Decision date
Received
(164 days to decision)
Product code
LFR Glucose Dehydrogenase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Diabetes Care, Inc. 1360 S. Loop Rd., Alameda CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFR

Trailing 12 months

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

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