AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
FDA 510(k) clearance K974620 · decided 1998-01-02
Clearance details
- K-number
- K974620
- Device name
- AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
- Applicant
- Trace America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-11
- Decision date
- 1998-01-02
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- JIF
- Device class
- 1
- Regulation number
- 862.1065
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnost recall (Z-0015-2008) | Thermo Fisher Scientific | 2007-10-04 |