510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841422Substantially Equivalent

Volume Test Dye 6

Reagent Laboratory, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841422 is the FDA 510(k) clearance record for VOLUME TEST DYE 6, a class I device, cleared for Reagent Laboratory, Inc. on under FDA product code JJO (Flame Emission Photometer For Clinical Use). FDA records list 19 510(k) clearances for Reagent Laboratory, Inc., from to . As of , FDA records show no recalls naming K841422.

Clearance record

Decision date
Received
(36 days to decision)
Product code
JJO Flame Emission Photometer For Clinical Use
Regulation
21 CFR 862.2540
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Reagent Laboratory, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JJO

Trailing 12 months

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

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