510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841183Substantially Equivalent

Sodium Chloride Solution Blood Cell

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

K841183 is the FDA 510(k) clearance record for SODIUM CHLORIDE SOLUTION BLOOD CELL, a class II device, cleared for Reagent Laboratory, Inc. on under FDA product code FNW (Pad, Kelly). FDA records list 19 510(k) clearances for Reagent Laboratory, Inc., from to . As of , FDA records show no recalls naming K841183.

Clearance record

Decision date
Received
(62 days to decision)
Product code
FNW Pad, Kelly
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Reagent Laboratory, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FNW

Trailing 12 months

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

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