The following data is part of a premarket notification filed by Norfolk Scientific, Inc. with the FDA for Qwikspin (tm).
Device ID | K860172 |
510k Number | K860172 |
Device Name: | QWIKSPIN (TM) |
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 | 1986-01-17 |
Decision Date | 1986-02-11 |