The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for E. Coli 0157 Latex Test.
| Device ID | K903714 |
| 510k Number | K903714 |
| Device Name: | E. COLI 0157 LATEX TEST |
| Classification | Antisera, All Types, Escherichia Coli |
| Applicant | PRO-LAB, INC. P.O. BOX 503 Round Rock, TX 78664 |
| Contact | Kay Baitz |
| Correspondent | Kay Baitz PRO-LAB, INC. P.O. BOX 503 Round Rock, TX 78664 |
| Product Code | GNA |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-14 |
| Decision Date | 1991-01-24 |