510(k) K871476
- Device
- SILVER STAIN REAGENT SYSTEM
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K871476
- Product code
- LEF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-21
- Date received
- 1987-04-14
- Regulation
- 864.1850
- Classification name
- Stains, Dye Powder
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM STARKWEATHER
- Address
- P.O. Box 14508 St. Louis MO US 63178 63178
FDA Registration Numbers#
- 1831638
- 3017248108
- 3021744379
- 2247035
- 1419341
- 1831338
- 3009432145
- 9610140
- 3007496191
- 1618982
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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