K100750 is an FDA 510(k) clearance for the AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJX).
Submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on May 21, 2010, 66 days after receiving the submission on March 16, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K100750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2010 |
| Decision Date | May 21, 2010 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |