The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000, Immulite 2500 Vancomycin.
| Device ID | K063045 |
| 510k Number | K063045 |
| Device Name: | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5210 PACIFIC CONCOURCE DR. Los Angeles, CA 90045 -6900 |
| Contact | Deborah L Morris |
| Correspondent | Deborah L Morris DIAGNOSTIC PRODUCTS CORP. 5210 PACIFIC CONCOURCE DR. Los Angeles, CA 90045 -6900 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-04 |
| Decision Date | 2006-12-05 |
| Summary: | summary |