AMYLASE (KINETIC) REAGENT SET
FDA 510(k) clearance K915704 · decided 1996-06-28
Clearance details
- K-number
- K915704
- Device name
- AMYLASE (KINETIC) REAGENT SET
- Applicant
- Tech Intl. Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-27
- Decision date
- 1996-06-28
- Days to decision
- 1675 days
- Clearance type
- Traditional
- Product code
- CJD
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Placentia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.