510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113793Substantially Equivalent

Homocysteine Test

Roche, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113793 is the FDA 510(k) clearance record for HOMOCYSTEINE TEST, a class II device, cleared for Roche on under FDA product code LPS (Urinary Homocystine (Nonquantitative) Test System). FDA records list 2 510(k) clearances for Roche, from to . As of , FDA records show 3 recalls naming K113793.

Clearance record

Decision date
Received
(165 days to decision)
Product code
LPS Urinary Homocystine (Nonquantitative) Test System
Regulation
21 CFR 862.1377
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LPS

Trailing 12 months

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

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