The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Shbg (modification).
| Device ID | K955440 |
| 510k Number | K955440 |
| Device Name: | IMMULITE SHBG (MODIFICATION) |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| 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 | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-23 |
| Decision Date | 1995-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414998947 | K955440 | 000 |
| 00630414972831 | K955440 | 000 |
| 00630414972916 | K955440 | 000 |
| 00630414966557 | K955440 | 000 |
| 00630414954226 | K955440 | 000 |