510(k) K841052
- Device
- CHOLESTEROL REAGENT SET
- Applicant
- MEDICAL SPECIALTIES, INC.
- 510(k) number
- K841052
- Product code
- CHD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-01
- Date received
- 1984-03-12
- Regulation
- 862.1175
- Classification name
- Acid, Ferric Ion-sulfuric, Cholesterol
- 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
FDA Registration Numbers#
- 3010830834
- 8040374
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CHD #
Legacy Summary#
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FDA Review#
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