Submission Details
| 510(k) Number | K931443 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 1993 |
| Decision Date | November 05, 1993 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
Nov 1993
Decision
228d
Days
Class 1
Risk
About This 510(k) Submission
K931443 is an FDA 510(k) clearance for the ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on November 5, 1993, 228 days after receiving the submission on March 22, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.
Device Classification
| Product Code | LSE — Epstein-barr Virus, Other |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3235 |
Manufacturer
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