The following data is part of a premarket notification filed by Portable Medical Laboratories, Inc. with the FDA for Specimen Collection & Transport System.
| Device ID | K844475 |
| 510k Number | K844475 |
| Device Name: | SPECIMEN COLLECTION & TRANSPORT SYSTEM |
| Classification | Syringe, Piston |
| Applicant | PORTABLE MEDICAL LABORATORIES, INC. P.O. BOX 667 Solana Beach, CA 92075 |
| Contact | Warren R Sanborn |
| Correspondent | Warren R Sanborn PORTABLE MEDICAL LABORATORIES, INC. P.O. BOX 667 Solana Beach, CA 92075 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-19 |
| Decision Date | 1985-02-06 |