510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080459Substantially Equivalent

Chromesytems Toxicology Calibrators and Controls

Chromsystems Instruments & Chemicals GmbH, Marietta GA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080459 is the FDA 510(k) clearance record for CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS, a class I device, cleared for Chromsystems Instruments & Chemicals GmbH on under FDA product code LAS (Drug Specific Control Materials). FDA records list one 510(k) clearance for Chromsystems Instruments & Chemicals GmbH. As of , FDA records show no recalls naming K080459.

Clearance record

Decision date
Received
(636 days to decision)
Product code
LAS Drug Specific Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Chromsystems Instruments & Chemicals GmbH 1733 Canton Ln., Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LAS

Trailing 12 months

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

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