510(k) K992799
- Device
- SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
- Applicant
- SANGUI BIOTECH, INC.
- 510(k) number
- K992799
- Product code
- GGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-06-07
- Date received
- 1999-08-19
- Regulation
- 864.7250
- Classification name
- Assay, Erythropoietin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN J KIANG
- Address
- 1508 Brookhollow Dr., #354 Santa Ana CA US 92705 92705
FDA Registration Numbers#
- 8032314
- 3002800697
- 1222302
- 2432235
- 2182501
- 2245285
- 2025099
- 3002806944
- 2122870
Source Documents#
Legacy Summary#
summary
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