The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Sample Capillary Plasma Sep W/lith Hepar.
| Device ID | K853152 |
| 510k Number | K853152 |
| Device Name: | MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-29 |
| Decision Date | 1985-08-23 |