SERIM(TM) BICARB PH REAGENT STRIPS— 510(k) K945491

Name: FDA 510(k) clearance K945491
Creator: U.S. Food and Drug Administration
Published: 1995-02-01

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K945491 for SERIM(TM) BICARB PH REAGENT STRIPS, Substantially Equivalent on 1995-02-01. Applicant: Serim Research Corp.. Device class: 2.

Clearance details

Applicant: Serim Research Corp.
Product code: Code MNV
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1994-11-08
Decision date: 1995-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNV

view all

K101750 — RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-01042011-01-07
K031267 — STERICHEK BICARB PH REAGENT STRIPS2003-12-23
K936311 — MITEK MINI ANCHOR1995-10-31
K941599 — MITEK ABSORBABLE ANCHOR1995-10-24
K944051 — ABSORBALBE ANCHOR1995-08-02

More clearances from Serim Research Corp.

view all

K120652 — RAPICIDE OPA-28 TEST STRIP2012-10-12
K092346 — SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 51712010-01-07
K083295 — SERIM DISINTEK GTA 2.1%, MODEL: 51642009-03-16
K082352 — SERIM DISINTEK OPA TEST STRIP2008-09-25
K081370 — SERIM DISINTEK OPA TEST STRIP2008-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.