The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Diluter, Lsa 290 Pipetter.
Device ID | K781883 |
510k Number | K781883 |
Device Name: | DILUTER, LSA 290 PIPETTER |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | KALLESTAD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-11-07 |
Decision Date | 1978-12-04 |