510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012975Substantially Equivalent

Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision Control Solutions

Abbott Medical, Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012975 is the FDA 510(k) clearance record for SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS, a class II device, cleared for Abbott Laboratories on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K012975.

Clearance record

Decision date
Received
(176 days to decision)
Product code
NBW System, Test, Blood Glucose, Over The Counter
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Laboratories 4-A Crosby Dr., Bedford MA
510(k) summary
Summary
Third party review
No

Clearances, product code NBW

Trailing 12 months
5 clearances under product code NBW in the twelve months to November 2026, October 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NBW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20263
November 20260