The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530.
| Device ID | K960434 |
| 510k Number | K960434 |
| Device Name: | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| 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 | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-31 |
| Decision Date | 1996-10-17 |
| Summary: | summary |