The following data is part of a premarket notification filed by Norfolk Scientific, Inc. with the FDA for Statspin Illuminated Micro-hematocrit Tube Reader.
| Device ID | K902028 |
| 510k Number | K902028 |
| Device Name: | STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER |
| Classification | Device, Hematocrit Measuring |
| 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 | JPI |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-04 |
| Decision Date | 1990-06-20 |