K961042 is an FDA 510(k) clearance for the MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL. This device is classified as a Instrument For Auto Reader Of Overnight Microorganism Identification System (Class I - General Controls, product code LRH).
Submitted by Dade Microscan, Inc. (West Sacramento, US). The FDA issued a Cleared decision on May 30, 1996, 77 days after receiving the submission on March 14, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K961042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1996 |
| Decision Date | May 30, 1996 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LRH — Instrument For Auto Reader Of Overnight Microorganism Identification System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |