The following data is part of a premarket notification filed by Los Alamos Diagnostics with the FDA for Resubmitted Utiscreen(tm) Bacterial Atp Test.
| Device ID | K883385 |
| 510k Number | K883385 |
| Device Name: | RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST |
| Classification | Kit, Screening, Urine |
| Applicant | LOS ALAMOS DIAGNOSTICS P.O. BOX 1221 2470 EAST ROAD Los Alamos, NM 87544 |
| Contact | Betty Strietelmeier |
| Correspondent | Betty Strietelmeier LOS ALAMOS DIAGNOSTICS P.O. BOX 1221 2470 EAST ROAD Los Alamos, NM 87544 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-09 |
| Decision Date | 1988-09-07 |