The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Anti-tpo-ab(lktoi,lkt05,lktoz.
| Device ID | K963695 |
| 510k Number | K963695 |
| Device Name: | IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine, Ph.d. |
| Correspondent | Edward M Levine, Ph.d. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1997-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964744 | K963695 | 000 |