K921977 is an FDA 510(k) clearance for the SYNERGY SCREEN TEST, MODIFICATION. This device is classified as a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II - Special Controls, product code LRG).
Submitted by Baxter Healthcare Corp (West Sacramento, US). The FDA issued a Cleared decision on October 12, 1993, 539 days after receiving the submission on April 21, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K921977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1992 |
| Decision Date | October 12, 1993 |
| Days to Decision | 539 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |