The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Homocysteine Model Lkho1 / Immulite 2000 Homocysteine Model L2kho2.
| Device ID | K003597 |
| 510k Number | K003597 |
| Device Name: | IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| 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 | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-21 |
| Decision Date | 2001-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964157 | K003597 | 000 |
| 00630414961620 | K003597 | 000 |
| 00630414953892 | K003597 | 000 |