The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Anti-tpo Ab, Model L2kt02, L2kt06.
| Device ID | K991096 |
| 510k Number | K991096 |
| Device Name: | IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 |
| Classification | System, Test, Thyroid Autoantibody |
| 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 | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414962153 | K991096 | 000 |
| 00630414962146 | K991096 | 000 |