510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013606Substantially Equivalent

Acs 180 Homocysteine Assay

Bayer Diagnostics Corp., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013606 is the FDA 510(k) clearance record for ACS 180 HOMOCYSTEINE ASSAY, a class II device, cleared for Bayer Diagnostics Corp. on under FDA product code LPS (Urinary Homocystine (Nonquantitative) Test System). FDA records list 32 510(k) clearances for Bayer Diagnostics Corp., from to . As of , FDA records show no recalls naming K013606.

Clearance record

Decision date
Received
(51 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
Bayer Diagnostics Corp. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
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