K832181 is an FDA 510(k) clearance for the SNO STRIPS STERILE TEARFLOW TEST STRIP. This device is classified as a Strip, Schirmer (Class I - General Controls, product code KYD).
Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 37 days after receiving the submission on July 6, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1800.
| 510(k) Number | K832181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1983 |
| Decision Date | August 12, 1983 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | KYD — Strip, Schirmer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1800 |