The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Theophylline.
| Device ID | K954569 |
| 510k Number | K954569 |
| Device Name: | IMMULITE THEOPHYLLINE |
| Classification | Enzyme Immunoassay, Theophylline |
| 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 | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1995-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414966571 | K954569 | 000 |
| 00630414966311 | K954569 | 000 |