Submission Details
| 510(k) Number | K072661 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 21, 2007 |
| Decision Date | November 20, 2007 |
| Days to Decision | 60 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Special
IMMUNOCAP THYRLOBULIN IMMUNOCAP
Nov 2007
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K072661 is an FDA 510(k) clearance for the IMMUNOCAP THYRLOBULIN IMMUNOCAP, a Immunochemical, Thyroglobulin Autoantibody (Class II — Special Controls, product code JNL), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on November 20, 2007, 60 days after receiving the submission on September 21, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.
Device Classification
| Product Code | JNL — Immunochemical, Thyroglobulin Autoantibody |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5870 |
Manufacturer
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