Submission Details
| 510(k) Number | K083117 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 22, 2008 |
| Decision Date | May 28, 2009 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
May 2009
Decision
218d
Days
Class 2
Risk
About This 510(k) Submission
K083117 is an FDA 510(k) clearance for the ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01, a Anti-rnp Antibody, Antigen And Control (Class II — Special Controls, product code LKO), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on May 28, 2009, 218 days after receiving the submission on October 22, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LKO — Anti-rnp Antibody, Antigen And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
Similar Devices — LKO Anti-rnp Antibody, Antigen And Control
All 22
K191085 · Genalyte, Inc.
· Oct 2019
K140224 · Euroimmun US
· Dec 2014
K123261 · Euroimmun US
· Jun 2013
K071210 · Biomedical Diagnostics (Bmd) SA
· Dec 2007
K022017 · Rhigene, Inc.
· Aug 2002
K000752 · Rhigene, Inc.
· May 2000
More from Phadia US, Inc.
View all
K141375
· DBM · Feb 2015
K140225
· MOB · Oct 2014
K132631
· LKP · Aug 2014
K131821
· MID · Dec 2013
K122197
· DHB · Aug 2013