The following data is part of a premarket notification filed by Pro-lab Diagnostics with the FDA for E.coli 0157 Latex Test.
| Device ID | K944421 |
| 510k Number | K944421 |
| Device Name: | E.COLI 0157 LATEX TEST |
| Classification | Antigens, All Types, Escherichia Coli |
| Applicant | PRO-LAB DIAGNOSTICS 20 MURAL ST. RICHMOND HILL Ontario, CA |
| Contact | Lynn Rae |
| Correspondent | Lynn Rae PRO-LAB DIAGNOSTICS 20 MURAL ST. RICHMOND HILL Ontario, CA |
| Product Code | GMZ |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-18 |
| Decision Date | 1994-12-15 |