The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite H. Pylori Igg And Immulite 2000 H. Pylori Igg.
| Device ID | K000463 |
| 510k Number | K000463 |
| Device Name: | IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG |
| Classification | Helicobacter Pylori |
| 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 | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-11 |
| Decision Date | 2000-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414989907 | K000463 | 000 |
| 00630414964164 | K000463 | 000 |
| 00630414961644 | K000463 | 000 |
| 00630414961637 | K000463 | 000 |
| 00630414960944 | K000463 | 000 |