K860641 is an FDA 510(k) clearance for the EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93. This device is classified as a Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase (Class I - General Controls, product code DLI).
Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on April 3, 1986, 42 days after receiving the submission on February 20, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3240.
| 510(k) Number | K860641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1986 |
| Decision Date | April 03, 1986 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DLI — Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3240 |