The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Turbo Ck-mb, Models Lskcp1, Lskcp5.
| Device ID | K991797 |
| 510k Number | K991797 |
| Device Name: | IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 |
| 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 | 1999-05-26 |
| Decision Date | 1999-06-09 |
| Summary: | summary |