PARA-PRO FC50— 510(k) K053257

Substantially Equivalent

Alpha-Tec Systems, Inc.

FDA 510(k) clearance K053257 for PARA-PRO FC50, Substantially Equivalent on 2006-05-12. Applicant: Alpha-Tec Systems, Inc.. Device class: 1.

Clearance details

Applicant: Alpha-Tec Systems, Inc.
Product code: Code LKS
Device class: Class 1
Regulation: 21 CFR 866.2900
Advisory panel: Microbiology
Date received: 2005-11-22
Decision date: 2006-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKS

K021420 — PARACON II/FECAL CONCENTRATOR II2002-06-04
K980077 — PARA-PAK SPINCON1998-04-02
K941110 — PARAKIT1994-05-17
K941129 — CON-KIT1994-05-09
K933370 — STOOL TRANSPORT/PROCESSOR1994-02-17

More clearances from Alpha-Tec Systems, Inc.

K890861 — ATS DOBELL & O'CONNOR'S IODINE1989-03-23
K890020 — ATS LUGOL'S IODINE SOLUTION1989-02-24
K890148 — ATS TB RAPID STAIN SET PRODUCT #034-451989-01-24
K890022 — ATS MAYER'S ALBUMIN1989-01-10
K883048 — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION1988-08-17

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