Submission Details
| 510(k) Number | K860138 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 14, 1986 |
| Decision Date | March 28, 1986 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
Cleared
Traditional
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
Mar 1986
Decision
73d
Days
Class 2
Risk
About This 510(k) Submission
K860138 is an FDA 510(k) clearance for the NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM, a Ceruloplasmin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDB), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 28, 1986, 73 days after receiving the submission on January 14, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5210.
Device Classification
| Product Code | DDB — Ceruloplasmin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5210 |
Manufacturer
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