The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Cmv Igg, Model L2kcv2, L2kcv6.
| Device ID | K993952 |
| 510k Number | K993952 |
| Device Name: | IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine |
| Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-22 |
| Decision Date | 1999-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414961231 | K993952 | 000 |