510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911628Substantially Equivalent

Serim Formaldehyde Reagent Strips (1.O% -2.0%)

Serim Research Corp., Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911628 is the FDA 510(k) clearance record for SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%), a class II device, cleared for Serim Research Corp. on under FDA product code LIF (Dialyzer Reprocessing System). FDA records list 31 510(k) clearances for Serim Research Corp., from to . As of , FDA records show no recalls naming K911628.

Clearance record

Decision date
Received
(77 days to decision)
Product code
LIF Dialyzer Reprocessing System
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Serim Research Corp. P.O. Box 4002, Elkhart IN
Third party review
No

Clearances, product code LIF

Trailing 12 months

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

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