The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Rubella Igm,lkrm1, Lkrm2, Immulite 2000 Rubella Igm, Model L2krm2, L2krm6.
Device ID | K012077 |
510k Number | K012077 |
Device Name: | IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 |
Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
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 | LFX |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-02 |
Decision Date | 2002-01-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414976716 | K012077 | 000 |
00630414971582 | K012077 | 000 |
00630414971469 | K012077 | 000 |