Submission Details
| 510(k) Number | K984135 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 1998 |
| Decision Date | May 26, 1999 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
May 1999
Decision
189d
Days
Class 2
Risk
About This 510(k) Submission
K984135 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR, a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQL), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 26, 1999, 189 days after receiving the submission on November 18, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.
Device Classification
| Product Code | GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3305 |
Manufacturer
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