Submission Details
| 510(k) Number | K984153 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 1998 |
| Decision Date | January 11, 1999 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
Jan 1999
Decision
53d
Days
Class 1
Risk
About This 510(k) Submission
K984153 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM., a Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I — General Controls, product code LJZ), submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on January 11, 1999, 53 days after receiving the submission on November 19, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.
Device Classification
| Product Code | LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3375 |
Manufacturer
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