The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Epstein-barr Viral Capsid Antigen (vca) Lgm Elisa Kit.
| Device ID | K946157 |
| 510k Number | K946157 |
| Device Name: | INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT |
| Classification | Epstein-barr Virus, Other |
| Applicant | INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | Mary L Frick |
| Correspondent | Mary L Frick INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1995-06-07 |