The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Modification To Immulite Myoglobin, Model Lkmy1, Lkmy5.
| Device ID | K991277 |
| 510k Number | K991277 |
| Device Name: | MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 |
| 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 | 1999-04-14 |
| Decision Date | 1999-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964270 | K991277 | 000 |
| 00630414961736 | K991277 | 000 |