The following data is part of a premarket notification filed by Biochemical Diagnostics, Inc. with the FDA for Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, Au/nz.
| Device ID | K132688 |
| 510k Number | K132688 |
| Device Name: | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ |
| Classification | Drug Mixture Control Materials |
| Applicant | BIOCHEMICAL DIAGNOSTICS, INC. 180 HEARTLAND BLVD. Edgewood, NY 11717 |
| Contact | Allen Panetz |
| Correspondent | Allen Panetz BIOCHEMICAL DIAGNOSTICS, INC. 180 HEARTLAND BLVD. Edgewood, NY 11717 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-28 |
| Decision Date | 2013-12-16 |
| Summary: | summary |