The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Thyroglobulin Model L2kty.
| Device ID | K982468 |
| 510k Number | K982468 |
| Device Name: | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY |
| Classification | System, Test, Thyroglobulin |
| 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 | MSW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-15 |
| Decision Date | 1999-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414972084 | K982468 | 000 |
| 00630414954318 | K982468 | 000 |