The following data is part of a premarket notification filed by Ram Scientific with the FDA for Safe-t-fill Capillary Blood Collection System.
| Device ID | K983517 |
| 510k Number | K983517 |
| Device Name: | SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | RAM SCIENTIFIC 1201 NEW YORK AVENUE N.W. SUITE 1000 Washington, DC 20005 |
| Contact | Geoffrey Levitt |
| Correspondent | Geoffrey Levitt RAM SCIENTIFIC 1201 NEW YORK AVENUE N.W. SUITE 1000 Washington, DC 20005 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-07 |
| Decision Date | 1998-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30643351000216 | K983517 | 000 |
| 30643351000117 | K983517 | 000 |
| 50643351000128 | K983517 | 000 |
| 50643351000203 | K983517 | 000 |
| 50643351000234 | K983517 | 000 |
| 50643351000098 | K983517 | 000 |
| 30643351000100 | K983517 | 000 |
| 30643351000148 | K983517 | 000 |
| 50643351000159 | K983517 | 000 |
| 50643351000166 | K983517 | 000 |
| 50643351000173 | K983517 | 000 |
| 30643351000186 | K983517 | 000 |
| 30643351000193 | K983517 | 000 |
| 50643351000081 | K983517 | 000 |