The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Ck-mb, Catalog # Lkcp1 (100 Tests), Lkcp5 (500 Tests).
| Device ID | K981495 |
| 510k Number | K981495 |
| Device Name: | IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) |
| Classification | Differential Rate Kinetic 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 | JHS |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-27 |
| Decision Date | 1998-06-10 |
| Summary: | summary |