The following data is part of a premarket notification filed by Biotest Diagnostics Corp. with the FDA for Cmv Brite Antigenemia Test Kit.
| Device ID | K951550 |
| 510k Number | K951550 |
| Device Name: | CMV BRITE ANTIGENEMIA TEST KIT |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | BIOTEST DIAGNOSTICS CORP. 66 FORD RD., SUITE 131 Denville, NJ 07834 |
| Contact | Patricia E Bonness |
| Correspondent | Patricia E Bonness BIOTEST DIAGNOSTICS CORP. 66 FORD RD., SUITE 131 Denville, NJ 07834 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-04 |
| Decision Date | 1996-01-30 |