510(k) K920370
- Device
- Isotypes Human Igg Subclass Eia Kit
- Applicant
- ISOTYPES, INC.
- 510(k) number
- K920370
- Product code
- CGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-11
- Date received
- 1992-01-28
- Regulation
- 866.5510
- Classification name
- Method, Immunodiffusion, Immunoglobulins (G, A, M)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARRY F CRISPIN
- Address
- P.O. Box 7022 Newark DE US 19714 19714
FDA Registration Numbers#
- 3019906