Submission Details
| 510(k) Number | K812308 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 17, 1981 |
| Decision Date | August 31, 1981 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
LANCER BUN RATE REAGENT KIT
Aug 1981
Decision
14d
Days
Class 2
Risk
About This 510(k) Submission
K812308 is an FDA 510(k) clearance for the LANCER BUN RATE REAGENT KIT, a Electrode, Ion Specific, Urea Nitrogen (Class II — Special Controls, product code CDS), submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981, 14 days after receiving the submission on August 17, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.
Device Classification
| Product Code | CDS — Electrode, Ion Specific, Urea Nitrogen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1770 |
Manufacturer
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