The following data is part of a premarket notification filed by Biotest Diagnostics Corp. with the FDA for Biotest Anti-ebv Recombinant, Ea Igm.
| Device ID | K983842 |
| 510k Number | K983842 |
| Device Name: | BIOTEST ANTI-EBV RECOMBINANT, EA IGM |
| Classification | Epstein-barr Virus, Other |
| Applicant | BIOTEST DIAGNOSTICS CORP. 66 FORD RD., SUITE 131 Denville, NJ 07834 |
| Contact | Patricia E Bonness |
| Correspondent | Patricia E Bonness BIOTEST DIAGNOSTICS CORP. 66 FORD RD., SUITE 131 Denville, NJ 07834 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-30 |
| Decision Date | 1999-06-09 |
| Summary: | summary |