AMYLASE (COLORIMETRIC) REAGENT SET— 510(k) K915710
Substantially EquivalentTech Intl. Co.
FDA 510(k) clearance K915710 for AMYLASE (COLORIMETRIC) REAGENT SET, Substantially Equivalent on 1992-01-30. Applicant: Tech Intl. Co.. Device class: 2.
Clearance details
- Applicant
- Tech Intl. Co.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester Hills, MI, US
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More clearances from Tech Intl. Co.
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