The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Quantex Igg.
| Device ID | K962202 |
| 510k Number | K962202 |
| Device Name: | QUANTEX IGG |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Betty J Lane |
| Correspondent | Betty J Lane INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-07 |
| Decision Date | 1996-09-26 |
| Summary: | summary |