Submission Details
| 510(k) Number | K991894 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 03, 1999 |
| Decision Date | May 24, 2000 |
| Days to Decision | 356 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
BIOSCANNER TRIGLYCERIDES TEST STRIPS
May 2000
Decision
356d
Days
Class 1
Risk
About This 510(k) Submission
K991894 is an FDA 510(k) clearance for the BIOSCANNER TRIGLYCERIDES TEST STRIPS, a Colorimetric Method, Triglycerides (Class I — General Controls, product code JGY), submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 24, 2000, 356 days after receiving the submission on June 3, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.
Device Classification
| Product Code | JGY — Colorimetric Method, Triglycerides |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1705 |
Manufacturer
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