The following data is part of a premarket notification filed by Portable Medical Laboratories, Inc. with the FDA for Rapid Diagnostic Kit.
| Device ID | K844442 |
| 510k Number | K844442 |
| Device Name: | RAPID DIAGNOSTIC KIT |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| 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 | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-16 |
| Decision Date | 1985-02-01 |