510(k) K895600
- Device
- Human (igg) Subclass (eia) Kit
- Applicant
- THE BINDING SITE, LTD.
- 510(k) number
- K895600
- Product code
- DAS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-11-08
- Date received
- 1989-09-18
- Regulation
- 866.5530
- Classification name
- Igg (Fc Fragment Specific), Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY H GELLER
- Address
- Westside Towers, Suite 1000 11845 W. Olympic Blvd. Los Angeles CA US 90064 90064
FDA Registration Numbers#
- 9610806
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DAS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K982023 | PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT | Inova Diagnostics, Inc. | 1998-09-04 |
| K944876 | HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT | Research Diagnostics, Inc. | 1994-12-15 |
| K943098 | HUMAN IGG SUBCLASSES ELISA COMBI KIT | Research Diagnostics, Inc. | 1994-09-07 |
| K943205 | HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) | Research Diagnostics, Inc. | 1994-09-07 |
| K790708 | ANTISERUM TO HUMAN IG G FC FRAGMENTS | Kent Laboratories, Inc. | 1979-08-22 |
| K790715 | ANTISERUM TO HUMAN FC | Kent Laboratories, Inc. | 1979-08-16 |
| K761156 | AMINOGLYCOSIDE CONTROLS | Supelco, Inc. | 1976-12-09 |