Submission Details
| 510(k) Number | K991610 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 10, 1999 |
| Decision Date | June 25, 1999 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
Jun 1999
Decision
46d
Days
Class 2
Risk
About This 510(k) Submission
K991610 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM., a Thyroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDC), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on June 25, 1999, 46 days after receiving the submission on May 10, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.
Device Classification
| Product Code | DDC — Thyroglobulin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5870 |
Manufacturer
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