The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiject Sys Capillary Blood Collect.
| Device ID | K833475 |
| 510k Number | K833475 |
| Device Name: | CAPIJECT SYS CAPILLARY BLOOD COLLECT |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | TERUMO MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-06 |
| Decision Date | 1983-12-08 |