510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033114Substantially Equivalent

Ketochecks

Neo Diagnostics, Inc., Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033114 is the FDA 510(k) clearance record for KETOCHECKS, a class I device, cleared for Neo Diagnostics, Inc. on under FDA product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)). FDA records list one 510(k) clearance for Neo Diagnostics, Inc. As of , FDA records show no recalls naming K033114.

Clearance record

Decision date
Received
(209 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
Neo Diagnostics, Inc. 10532 Walker St., Cypress 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