510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875248Substantially Equivalent

Bioscan Urine Diagnostic Reagent Strips

Bioscan Instruments, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875248 is the FDA 510(k) clearance record for BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS, a class I device, cleared for Bioscan Instruments, Inc. on under FDA product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)). FDA records list 2 510(k) clearances for Bioscan Instruments, Inc., from to . As of , FDA records show no recalls naming K875248.

Clearance record

Decision date
Received
(64 days to decision)
Product code
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Regulation
21 CFR 862.1510
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bioscan Instruments, Inc. 39w 32nd St., New York NY
Third party review
No

Clearances, product code JMT

Trailing 12 months
1 clearance under product code JMT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JMT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260