The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Epstein-barr Vir Early Anti Diff Igg Clin-elisa.
| Device ID | K921628 |
| 510k Number | K921628 |
| Device Name: | EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA |
| Classification | Epstein-barr Virus, Other |
| Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Contact | Mary Frick |
| Correspondent | Mary Frick INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-09-14 |