The following data is part of a premarket notification filed by Microbiological Research Corp. with the FDA for Cmv Test.
| Device ID | K843138 |
| 510k Number | K843138 |
| Device Name: | CMV TEST |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | MICROBIOLOGICAL RESEARCH CORP. P.O. BOX 308 Bountiful, UT 84010 |
| Contact | Carole A Golden |
| Correspondent | Carole A Golden MICROBIOLOGICAL RESEARCH CORP. P.O. BOX 308 Bountiful, UT 84010 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-09 |
| Decision Date | 1985-01-29 |