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 |