Submission Details
| 510(k) Number | K972297 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 19, 1997 |
| Decision Date | July 17, 1997 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Jul 1997
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K972297 is an FDA 510(k) clearance for the AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST), a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on July 17, 1997, 28 days after receiving the submission on June 19, 1997. 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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