Submission Details
| 510(k) Number | K831909 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 14, 1983 |
| Decision Date | July 18, 1983 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
Cleared
Traditional
RABBIT ANTISERUM TO HUMAN IGA
Jul 1983
Decision
34d
Days
Class 2
Risk
About This 510(k) Submission
K831909 is an FDA 510(k) clearance for the RABBIT ANTISERUM TO HUMAN IGA, a Iga, Fitc, Antigen, Antiserum, Control (Class II — Special Controls, product code CZN), submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983, 34 days after receiving the submission on June 14, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.
Device Classification
| Product Code | CZN — Iga, Fitc, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
Manufacturer
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