K984153 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3375.
| 510(k) Number | K984153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3375 |