K971672 is an FDA 510(k) clearance for the SERAQUEST TOXOPLASMA IGM. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II - Special Controls, product code LGD).
Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on October 21, 1997, 167 days after receiving the submission on May 7, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K971672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1997 |
| Decision Date | October 21, 1997 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |