K900821 is an FDA 510(k) clearance for the AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING. This device is classified as a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II - Special Controls, product code LRG).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 15, 1990, 22 days after receiving the submission on February 21, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K900821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1990 |
| Decision Date | March 15, 1990 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |