The following data is part of a premarket notification filed by Portable Medical Laboratories, Inc. with the FDA for Urinoscopy Funnel.
Device ID | K871671 |
510k Number | K871671 |
Device Name: | URINOSCOPY FUNNEL |
Classification | Hemocytometer |
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 | GHO |
CFR Regulation Number | 864.6160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-28 |
Decision Date | 1987-05-20 |