K853546 is an FDA 510(k) clearance for the ABBOTT CATION SUPPLEMENT SOLUTION. This device is classified as a Supplement, Culture Media (Class I - General Controls, product code JSK).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on September 6, 1985, 11 days after receiving the submission on August 26, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2450.
| 510(k) Number | K853546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1985 |
| Decision Date | September 06, 1985 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSK — Supplement, Culture Media |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2450 |