The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Toxoplasma Igm Capture Elisa Assay.
| Device ID | K963289 |
| 510k Number | K963289 |
| Device Name: | INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| 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 | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-21 |
| Decision Date | 1997-05-01 |
| Summary: | summary |