K971393 is an FDA 510(k) clearance for the MYCOPLASMA IGG ELISA TEST SYSTEM. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I - General Controls, product code LJZ).
Submitted by Immunoprobe, Inc. (Frederick, US). The FDA issued a Cleared decision on July 14, 1997, 96 days after receiving the submission on April 9, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3375.
| 510(k) Number | K971393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1997 |
| Decision Date | July 14, 1997 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3375 |