The following data is part of a premarket notification filed by Bio Diagnostic Intl. with the FDA for Liqui-sera Combo Ligand/tdm Controls.
| Device ID | K863849 |
| 510k Number | K863849 |
| Device Name: | LIQUI-SERA COMBO LIGAND/TDM CONTROLS |
| 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 | 1986-09-30 |
| Decision Date | 1986-11-24 |