The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Cmv-vue(tm) Cmv Antigen Detection Kit.
| Device ID | K921616 |
| 510k Number | K921616 |
| Device Name: | CMV-VUE(TM) CMV ANTIGEN DETECTION KIT |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| 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 | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-08-11 |