The following data is part of a premarket notification filed by E-y Laboratories, Inc. with the FDA for Strep-a-chek.
| Device ID | K934129 |
| 510k Number | K934129 |
| Device Name: | STREP-A-CHEK |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | E-Y LABORATORIES, INC. P.O. BOX 1787 107 N. AMPHLETT BOULEVARD San Mateo, CA 94401 |
| Contact | Linda M Wertz |
| Correspondent | Linda M Wertz E-Y LABORATORIES, INC. P.O. BOX 1787 107 N. AMPHLETT BOULEVARD San Mateo, CA 94401 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-12 |
| Decision Date | 1994-08-26 |