510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060768Substantially Equivalent

Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test Strips

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

K060768 is the FDA 510(k) clearance record for PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS, a class I device, cleared for Abbott Diabetes Care, Inc. on under FDA product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show one recall naming K060768.

Clearance record

Decision date
Received
(30 days to decision)
Product code
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation
21 CFR 862.1435
Device class
Class I
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 JIN

Trailing 12 months

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

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