The following data is part of a premarket notification filed by Diagnostic Products Corporation with the FDA for Immulite 2500 Vitamin B12 Model L5kvb2-200 Test,l5kvb6-600 Test, Immulite 2500 Folic Acid Model L5kfo2-200 Test,l5kfo6-6.
| Device ID | K060929 |
| 510k Number | K060929 |
| Device Name: | IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | DIAGNOSTIC PRODUCTS CORPORATION 5210 PACIFIC CONCOURSE DR. Los Angeles, CA 90045 -6900 |
| Contact | Deborah L Morris |
| Correspondent | Deborah L Morris DIAGNOSTIC PRODUCTS CORPORATION 5210 PACIFIC CONCOURSE DR. Los Angeles, CA 90045 -6900 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-05 |
| Decision Date | 2006-04-28 |
| Summary: | summary |