The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Turbo Ck-mb, Models Lskcp1 (100 Tests), Lskcp5 (500 Tests).
| Device ID | K022118 |
| 510k Number | K022118 |
| Device Name: | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-01 |
| Decision Date | 2002-07-22 |
| Summary: | summary |