510(k) K831874
- Device
- LIPASE REAGENT SET
- Applicant
- STERLING BIOCHEMICAL, INC.
- 510(k) number
- K831874
- Product code
- JGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-08-12
- Date received
- 1983-06-13
- Regulation
- 862.1705
- Classification name
- Turbidimetric Method, Triglycerides
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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