510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K043031Substantially Equivalent

Serim Dialysate Monitor Test Strip

Serim Research Corp., Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043031 is the FDA 510(k) clearance record for SERIM DIALYSATE MONITOR TEST STRIP, a class II device, cleared for Serim Research Corp. on under FDA product code NTZ (Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator). FDA's definition for product code NTZ reads: "Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate". FDA records list 31 510(k) clearances for Serim Research Corp., from to . As of , FDA records show no recalls naming K043031.

Clearance record

Decision date
Received
(222 days to decision)
Product code
NTZ Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Serim Research Corp. 23565 Reedy Dr., Elkhart IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTZ

Trailing 12 months

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

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