The following data is part of a premarket notification filed by Statspin Technologies with the FDA for Statspin Micro-hematocrit Reader For 75mm Tubes.
| Device ID | K903698 |
| 510k Number | K903698 |
| Device Name: | STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES |
| Classification | Device, Hematocrit Measuring |
| Applicant | STATSPIN TECHNOLOGIES 85 MORSE ST. Norwood, MA 02062 |
| Contact | Thomas Kelley |
| Correspondent | Thomas Kelley STATSPIN TECHNOLOGIES 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 | 1990-08-15 |
| Decision Date | 1990-09-17 |