510(k) K915704
- Device
- AMYLASE (KINETIC) REAGENT SET
- Applicant
- TECH INTL. CO.
- 510(k) number
- K915704
- Product code
- CJD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-28
- Date received
- 1991-11-27
- Regulation
- 862.1070
- Classification name
- Nitrosalicylate Reduction, Amylase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHEN
- Address
- 911 Via Rodeo Placentia CA US 92670 92670
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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