The following data is part of a premarket notification filed by Remel, Inc. with the FDA for Gram Swab.
| Device ID | K970834 |
| 510k Number | K970834 |
| Device Name: | GRAM SWAB |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | REMEL, INC. 12076 SANTA FE DR. Lenexa, KS 66215 -3594 |
| Contact | Mary A Silvius |
| Correspondent | Mary A Silvius REMEL, INC. 12076 SANTA FE DR. Lenexa, KS 66215 -3594 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-04-17 |