Submission Details
| 510(k) Number | K993741 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 04, 1999 |
| Decision Date | July 03, 2000 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
EZ LDL CHOLESTEROL TEST SYSTEM
Jul 2000
Decision
242d
Days
Class 1
Risk
About This 510(k) Submission
K993741 is an FDA 510(k) clearance for the EZ LDL CHOLESTEROL TEST SYSTEM, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 3, 2000, 242 days after receiving the submission on November 4, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.
Device Classification
| Product Code | MRR — System, Test, Low Density, Lipoprotein |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1475 |
Manufacturer
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