RIM E.COLI 0157:H7 LATEX TEST— 510(k) K933457

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K933457 for RIM E.COLI 0157:H7 LATEX TEST, Substantially Equivalent on 1994-04-20. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant: Remel Co.
Product code: Code GNA
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1993-07-14
Decision date: 1994-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNA

K071799 — MODIFICATION TO BIOSTAR OIA SHIGATOX2007-10-02
K031367 — DUOPATH VEROTOXINS GLISA TEST2004-01-23
K993401 — DRYSPOT E.COLI 0157 KIT2000-02-28
K981734 — VTEC-RPLA SEIKEN1998-09-22
K962028 — WELLCOLEX E-COLI OI57 ZC601996-11-01

More clearances from Remel Co.

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