The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Architect Anti-tpo Immunoassay, Calibrators & Controls.
| Device ID | K052407 |
| 510k Number | K052407 |
| Device Name: | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown, VA 22645 -0307 |
| Contact | M. Heather Cameron |
| Correspondent | M. Heather Cameron FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown, VA 22645 -0307 |
| Product Code | JZO |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-01 |
| Decision Date | 2006-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740048327 | K052407 | 000 |
| 00380740003463 | K052407 | 000 |
| 00380740003456 | K052407 | 000 |