The following data is part of a premarket notification filed by Biocell Laboratories, Inc. with the FDA for Bio-csf Liquid Control Level 1 And 2.
Device ID | K963551 |
510k Number | K963551 |
Device Name: | BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | BIOCELL LABORATORIES, INC. 2001 UNIVERSITY DR. Rancho Dominguez, CA 90220 -6411 |
Contact | Marc M Mckonic |
Correspondent | Marc M Mckonic BIOCELL LABORATORIES, INC. 2001 UNIVERSITY DR. Rancho Dominguez, CA 90220 -6411 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-05 |
Decision Date | 1996-10-07 |