The following data is part of a premarket notification filed by Kenlor Industries, Inc. with the FDA for Kenlor Human Spinal Fluid Control Liquid.
Device ID | K890576 |
510k Number | K890576 |
Device Name: | KENLOR HUMAN SPINAL FLUID CONTROL LIQUID |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | KENLOR INDUSTRIES, INC. 8130 MCFADDEN AVE., SUITE 105 Westminster, CA 92683 |
Contact | Som, Ph.d. |
Correspondent | Som, Ph.d. KENLOR INDUSTRIES, INC. 8130 MCFADDEN AVE., SUITE 105 Westminster, CA 92683 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-06 |
Decision Date | 1989-03-09 |