The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Ck-mb, Model Lkmb1 (100 Tests), Lkmb5 (500 Tests); Immulite 2000 Ck-mb, Model L2kmb2 (200 Tests), L2kmb6 (600).
| Device ID | K004002 |
| 510k Number | K004002 |
| Device Name: | IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| 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 | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-02-14 |