The following data is part of a premarket notification filed by Bio Diagnostic Intl. with the FDA for Liqui-sera Spinal Fluid Control.
Device ID | K874459 |
510k Number | K874459 |
Device Name: | LIQUI-SERA SPINAL FLUID CONTROL |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | BIO DIAGNOSTIC INTL. 1251 - Q SOUTH BEACH BLVD. La Habra, CA 90631 |
Contact | Anand, Phd |
Correspondent | Anand, Phd BIO DIAGNOSTIC INTL. 1251 - Q SOUTH BEACH BLVD. La Habra, CA 90631 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-29 |
Decision Date | 1987-12-29 |