The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Turbo Myoglobin, Models Lskmy1, Lskmy5.
| Device ID | K991796 |
| 510k Number | K991796 |
| Device Name: | IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| 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 | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964942 | K991796 | 000 |