K920225 is an FDA 510(k) clearance for the AUTOSCEPTOR IDENTIFICATION SYSTEM. This device is classified as a Instrument For Auto Reader Of Overnight Microorganism Identification System (Class I - General Controls, product code LRH).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 22, 1992, 126 days after receiving the submission on January 17, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K920225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 1992 |
| Decision Date | May 22, 1992 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LRH — Instrument For Auto Reader Of Overnight Microorganism Identification System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |