The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Quantex Aso-crp-rp Control Ii.
| Device ID | K984437 |
| 510k Number | K984437 |
| Device Name: | QUANTEX ASO-CRP-RP CONTROL II |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-14 |
| Decision Date | 1999-02-02 |
| Summary: | summary |