The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Pico Models 30, 50, 70.
| Device ID | K962158 |
| 510k Number | K962158 |
| Device Name: | PICO MODELS 30, 50, 70 |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Donald L Baker |
| Correspondent | Donald L Baker RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-04 |
| Decision Date | 1996-10-29 |
| Summary: | summary |