The following data is part of a premarket notification filed by Gibson Laboratories, Inc. with the FDA for Gibson Id A.e. Test.
| Device ID | K953247 |
| 510k Number | K953247 |
| Device Name: | GIBSON ID A.E. TEST |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | GIBSON LABORATORIES, INC. 1040 MANCHESTER ST. Lexington, KY 40508 |
| Contact | Naomi Bowling |
| Correspondent | Naomi Bowling GIBSON LABORATORIES, INC. 1040 MANCHESTER ST. Lexington, KY 40508 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-11 |
| Decision Date | 1995-11-20 |