K973508 is an FDA 510(k) clearance for the PYLORI DETECT IGG. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Micro Detect, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on March 10, 1998, 175 days after receiving the submission on September 16, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K973508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 1997 |
| Decision Date | March 10, 1998 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LYR — Helicobacter Pylori |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |