The following data is part of a premarket notification filed by Analytical Luminescence Laboratory, Inc. with the FDA for Microstatic Urine Transport Tube For C & S.
| Device ID | K851387 |
| 510k Number | K851387 |
| Device Name: | MICROSTATIC URINE TRANSPORT TUBE FOR C & S |
| Classification | Device, Specimen Collection |
| Applicant | ANALYTICAL LUMINESCENCE LABORATORY, INC. 11760 SORRENTO VALLEY RD.#E San Diego, CA 92121 |
| Contact | Jon C Wannlund |
| Correspondent | Jon C Wannlund ANALYTICAL LUMINESCENCE LABORATORY, INC. 11760 SORRENTO VALLEY RD.#E San Diego, CA 92121 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-05-20 |