The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Blood Specimen Collection Devices.
| Device ID | K863491 |
| 510k Number | K863491 |
| Device Name: | BLOOD SPECIMEN COLLECTION DEVICES |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Contact | Docal, M.d. |
| Correspondent | Docal, M.d. MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-08 |
| Decision Date | 1986-10-24 |