Cleared Abbreviated

RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2

K031101 · Hemagen Diagnostics, Inc. · Chemistry
Jun 2003
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K031101 is an FDA 510(k) clearance for the RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on June 16, 2003, 70 days after receiving the submission on April 7, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K031101 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2003
Decision Date June 16, 2003
Days to Decision 70 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJY Multi-analyte Controls, All Kinds (assayed)

All 672
Multichem IA Plus
K162530 · Techno-Path Manufacturing · Mar 2017
Audit MicroControls Linearity FD Tumor Markers II
K163629 · Aalto Scientific, Ltd. · Mar 2017
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
K163015 · Bio-Rad Laboratories · Jan 2017
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
K153712 · Radiometer America, Inc. · Jan 2016
Liquichek Cardiac Markers Plus Control LT
K150300 · Bio-Rad Laboratories · Dec 2015
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
K142964 · Maine Standards Company, LLC · Apr 2015