510(k) K790042
- Device
- STAIN, HEMASTAIN RETIC
- Applicant
- GEOMETRIC DATA, DIV. SMITHKLINE CORP.
- 510(k) number
- K790042
- Product code
- GJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-02-15
- Date received
- 1979-01-05
- Regulation
- 864.1850
- Classification name
- Stain, Reticulocyte
- Medical specialty
- Hematology
- Review panel
- Hematology
- 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#
- 1125908
- 3010188738
- 9613959
- 3010421384
- 3016438761
- 1625587
- 1937990
- 1831638
- 3005626422
- 3002809144
- 2243072
- 3002805583
- 1711690
- 1181121
- 3009711478
- 3006365273
- 3008344661
- 3016741564
- 1000138378
- 2013736
- 3005333358
- 2250039
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases