The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Myoglobin, Model Lkmy1 And Lkmy5.
Device ID | K983970 |
510k Number | K983970 |
Device Name: | IMMULITE MYOGLOBIN, MODEL LKMY1 AND 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-09 |
Decision Date | 1998-11-25 |
Summary: | summary |