Submission Details
| 510(k) Number | K984181 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 23, 1998 |
| Decision Date | January 22, 1999 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
Jan 1999
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K984181 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II — Special Controls, product code LFY), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 22, 1999, 60 days after receiving the submission on November 23, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.
Device Classification
| Product Code | LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3900 |
Manufacturer
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