The following data is part of a premarket notification filed by Alimenterics, Inc. with the FDA for Alimenterics Lara (tm) Breath Test System.
| Device ID | K973000 |
| 510k Number | K973000 |
| Device Name: | ALIMENTERICS LARA (TM) BREATH TEST SYSTEM |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | ALIMENTERICS, INC. 301 AMERICAN RD. Morris Plains, NJ 07950 |
| Contact | Janet G Murnick |
| Correspondent | Janet G Murnick ALIMENTERICS, INC. 301 AMERICAN RD. Morris Plains, NJ 07950 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-12 |
| Decision Date | 1998-02-26 |
| Summary: | summary |