The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for X-act Urea/tda.
| Device ID | K883995 |
| 510k Number | K883995 |
| Device Name: | X-ACT UREA/TDA |
| Classification | Culture Media, Multiple Biochemical Test |
| Applicant | PRO-LAB, INC. 290 LARKIN ST. P.O. BOX 1099 Buffalo, NY 14210 |
| Contact | Kay Baitz |
| Correspondent | Kay Baitz PRO-LAB, INC. 290 LARKIN ST. P.O. BOX 1099 Buffalo, NY 14210 |
| Product Code | JSE |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-20 |
| Decision Date | 1988-10-12 |