510(k) K790708
- Device
- ANTISERUM TO HUMAN IG G FC FRAGMENTS
- Applicant
- KENT LABORATORIES, INC.
- 510(k) number
- K790708
- Product code
- DAS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-08-22
- Date received
- 1979-04-12
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K895600 | HUMAN (IGG) SUBCLASS (EIA) KIT | The Binding Site, Ltd. | 1989-11-08 |
| K790715 | ANTISERUM TO HUMAN FC | Kent Laboratories, Inc. | 1979-08-16 |
| K761156 | AMINOGLYCOSIDE CONTROLS | Supelco, Inc. | 1976-12-09 |
Legacy Summary#
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FDA Review#
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