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 | K981973 |
| 510k Number | K981973 |
| 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 | 1998-06-05 |
| Decision Date | 1998-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50643351000074 | K981973 | 000 |
| 50643351000067 | K981973 | 000 |
| 50643351000050 | K981973 | 000 |
| 50643351000043 | K981973 | 000 |
| 30643351000032 | K981973 | 000 |
| 30643351000025 | K981973 | 000 |
| 50643351000012 | K981973 | 000 |