Submission Details
| 510(k) Number | K000363 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 2000 |
| Decision Date | February 18, 2000 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Special
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
Feb 2000
Decision
14d
Days
Class 2
Risk
About This 510(k) Submission
K000363 is an FDA 510(k) clearance for the MODIFICATION TO 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. (Raritan, US). The FDA issued a Cleared decision on February 18, 2000, 14 days after receiving the submission on February 4, 2000. 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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