The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Microcult-gc Culture Test.
| Device ID | K781108 |
| 510k Number | K781108 |
| Device Name: | MICROCULT-GC CULTURE TEST |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-30 |
| Decision Date | 1978-08-31 |