The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2500 Ck-mb, 2500 Myoglobin, 2500 Stat Troponin I.
| Device ID | K034055 |
| 510k Number | K034055 |
| Device Name: | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine, Ph.d. |
| Correspondent | Edward M Levine, Ph.d. DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JHX |
| Subsequent Product Code | DDR |
| Subsequent Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-30 |
| Decision Date | 2004-01-21 |
| Summary: | summary |