The following data is part of a premarket notification filed by Norfolk Scientific, Inc. with the FDA for Statspin Disposable Rotor, Product #rd01.
| Device ID | K881254 |
| 510k Number | K881254 |
| Device Name: | STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood, MA 02062 |
| Contact | Thomas F Kelley,phd |
| Correspondent | Thomas F Kelley,phd NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood, MA 02062 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-23 |
| Decision Date | 1988-04-05 |