The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite C-reactive Protein, Models Lkc1, Lkc5.
Device ID | K984132 |
510k Number | K984132 |
Device Name: | IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 |
Classification | C-reactive Protein, Antigen, Antiserum, And 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 | DCK |
CFR Regulation Number | 866.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-18 |
Decision Date | 1999-01-28 |
Summary: | summary |