The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Hsz I/ii Igg Elisa Assay.
| Device ID | K955363 |
| 510k Number | K955363 |
| Device Name: | INCSTAR HSZ I/II IGG ELISA ASSAY |
| Classification | Formalin-saline |
| Applicant | INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | Mary Frick |
| Correspondent | Mary Frick INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
| Product Code | IGC |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-22 |
| Decision Date | 1996-07-24 |
| Summary: | summary |