The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 1000 Automated Immunoassay Analyzer.
| Device ID | K022603 |
| 510k Number | K022603 |
| Device Name: | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| 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 | CEW |
| Subsequent Product Code | CDD |
| Subsequent Product Code | CDP |
| Subsequent Product Code | CDZ |
| Subsequent Product Code | CEC |
| Subsequent Product Code | CEE |
| Subsequent Product Code | CEP |
| Subsequent Product Code | CFL |
| Subsequent Product Code | CFP |
| Subsequent Product Code | CFT |
| Subsequent Product Code | CGI |
| Subsequent Product Code | CGJ |
| Subsequent Product Code | CGN |
| Subsequent Product Code | CGR |
| Subsequent Product Code | CGT |
| Subsequent Product Code | CHP |
| Subsequent Product Code | CKG |
| Subsequent Product Code | DCN |
| Subsequent Product Code | DDR |
| Subsequent Product Code | DFJ |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-06 |
| Decision Date | 2002-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964096 | K022603 | 000 |
| 00630414966014 | K022603 | 000 |
| 00630414966045 | K022603 | 000 |
| 00630414966243 | K022603 | 000 |
| 00630414998954 | K022603 | 000 |
| 00630414947440 | K022603 | 000 |
| 00630414953106 | K022603 | 000 |
| 00630414953526 | K022603 | 000 |
| 00630414961569 | K022603 | 000 |
| 00630414954035 | K022603 | 000 |