Submission Details
| 510(k) Number | K123021 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2012 |
| Decision Date | November 02, 2012 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
BIOPLEX 2200 EBV IGM KIT
Nov 2012
Decision
36d
Days
Class 1
Risk
About This 510(k) Submission
K123021 is an FDA 510(k) clearance for the BIOPLEX 2200 EBV IGM KIT, a Antibody Igm, If, Epstein-barr Virus (Class I — General Controls, product code LJN), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on November 2, 2012, 36 days after receiving the submission on September 27, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.
Device Classification
| Product Code | LJN — Antibody Igm, If, Epstein-barr Virus |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3235 |
Manufacturer
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