Submission Details
| 510(k) Number | K042689 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2004 |
| Decision Date | December 09, 2004 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
NICHOLS ADVANTAGE CORTISOL
Dec 2004
Decision
71d
Days
Class 2
Risk
About This 510(k) Submission
K042689 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CORTISOL, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on December 9, 2004, 71 days after receiving the submission on September 29, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.
Device Classification
| Product Code | CGR — Radioimmunoassay, Cortisol |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1205 |
Manufacturer
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