Submission Details
| 510(k) Number | K991179 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1999 |
| Decision Date | June 17, 1999 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
Jun 1999
Decision
71d
Days
Class 2
Risk
About This 510(k) Submission
K991179 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC., THYROGLOBULIN 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 17, 1999, 71 days after receiving the submission on April 7, 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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