Submission Details
| 510(k) Number | K930002 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 EBNA-IFF ANTIBODY ELISA
Jul 1993
Decision
193d
Days
Class 1
Risk
About This 510(k) Submission
K930002 is an FDA 510(k) clearance for the ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA, a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), 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 | LLM — Test, Antigen, Nuclear, Epstein-barr Virus |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3235 |
Manufacturer
Similar Devices — LLM Test, Antigen, Nuclear, Epstein-barr Virus
All 26
K233605 · Biokit, S.A.
· Aug 2024
K040120 · DiaSorin, Inc.
· Apr 2005
K984133 · Zeus Scientific, Inc.
· Jan 1999
K973941 · Genbio
· Aug 1998
K980598 · Clark Laboratories, Inc.
· May 1998
K951549 · Immunoprobe, Inc.
· Apr 1996
More from Ortho Diagnostic Systems, Inc.
View all
K951459
· GKZ · Jul 1997
K951632
· GKZ · Mar 1997
K964754
· GKZ · Jan 1997
K963902
· GIS · Nov 1996
K950568
· GKZ · May 1996