Submission Details
| 510(k) Number | K001569 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 19, 2000 |
| Decision Date | June 26, 2000 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
Jun 2000
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K001569 is an FDA 510(k) clearance for the INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568), a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 26, 2000, 38 days after receiving the submission on May 19, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.
Device Classification
| Product Code | JFJ — Catalytic Methods, Amylase |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1070 |
Manufacturer
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