Submission Details
| 510(k) Number | K930020 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 04, 1993 |
| Decision Date | July 16, 1993 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
Jul 1993
Decision
193d
Days
Class 1
Risk
About This 510(k) Submission
K930020 is an FDA 510(k) clearance for the ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA, a Antibody Igm, If, Epstein-barr Virus (Class I — General Controls, product code LJN), submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on July 16, 1993, 193 days after receiving the submission on January 4, 1993. 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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