The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for General Diagnostics Rapid E. Coli Test.
| Device ID | K852889 |
| 510k Number | K852889 |
| Device Name: | GENERAL DIAGNOSTICS RAPID E. COLI TEST |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
| Contact | Lynn Decaro |
| Correspondent | Lynn Decaro WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-07-23 |