K860301 is an FDA 510(k) clearance for the RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE. This device is classified as a Discs, Strips And Reagents, Microorganism Differentiation (Class I - General Controls, product code JTO).
Submitted by Carr-Scarborough Microbiologicals, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on February 6, 1986, 9 days after receiving the submission on January 28, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K860301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1986 |
| Decision Date | February 06, 1986 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTO — Discs, Strips And Reagents, Microorganism Differentiation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |