510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984485Substantially Equivalent

Microstat 2

Chemlink Laboratories, LLC., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984485 is the FDA 510(k) clearance record for MICROSTAT 2, a class I device, cleared for Chemlink Laboratories, LLC on under FDA product code LRJ (Disinfectant, Medical Devices). FDA records list one 510(k) clearance for Chemlink Laboratories, LLC. As of , FDA records show no recalls naming K984485.

Clearance record

Decision date
Received
(27 days to decision)
Product code
LRJ Disinfectant, Medical Devices
Regulation
21 CFR 880.6890
Device class
Class I
Review panel
General Hospital
Applicant
Chemlink Laboratories, LLC 122 C St., NW,, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code LRJ

Trailing 12 months

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

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