Submission Details
| 510(k) Number | K941698 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 1994 |
| Decision Date | July 28, 1994 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
SERUM VOLATILES CONTROL - LEVELS 1 AND 2
Jul 1994
Decision
113d
Days
Class 1
Risk
About This 510(k) Submission
K941698 is an FDA 510(k) clearance for the SERUM VOLATILES CONTROL - LEVELS 1 AND 2, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on July 28, 1994, 113 days after receiving the submission on April 6, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
Similar Devices — JJY Multi-analyte Controls, All Kinds (assayed)
All 672
K162530 · Techno-Path Manufacturing
· Mar 2017
K163629 · Aalto Scientific, Ltd.
· Mar 2017
K163015 · Bio-Rad Laboratories
· Jan 2017
K153712 · Radiometer America, Inc.
· Jan 2016
K150300 · Bio-Rad Laboratories
· Dec 2015
K142964 · Maine Standards Company, LLC
· Apr 2015
More from More Diagnostics
View all
K072257
· LAS · Jan 2008
K050125
· JJY · Mar 2005
K982845
· JJT · Aug 1998
K980331
· DIF · Mar 1998
K972976
· JJT · Aug 1997