The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Lkb 2160 Midispin Centrifuge.
Device ID | K831947 |
510k Number | K831947 |
Device Name: | LKB 2160 MIDISPIN CENTRIFUGE |
Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
Applicant | LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQC |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-16 |
Decision Date | 1983-07-29 |