The following data is part of a premarket notification filed by Norfolk Scientific, Inc. with the FDA for Statspin Hdl-cholesterol Precipitating Micro Tube.
| Device ID | K890669 |
| 510k Number | K890669 |
| Device Name: | STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood, MA 02062 |
| Contact | Kelley, Phd |
| Correspondent | Kelley, Phd NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood, MA 02062 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-09 |
| Decision Date | 1989-03-08 |