510(k) K881827
- Device
- IMMUNOGLOBULIN A TEST SYSTEM
- Applicant
- THE BINDING SITE, LTD.
- 510(k) number
- K881827
- Product code
- CFQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-06-10
- Date received
- 1988-04-29
- Regulation
- 866.5510
- Classification name
- Radioimmunoassay, Immunoglobulins (g, A, M)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- 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#
- 3005360469
- 3010825766
- 2517506
- 2020726
- 1618982
- 3006198300
- 3003601075
- 1319436
- 9610806
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CFQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981786 | IGA MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-11-24 |
| K990551 | IGG FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-03-25 |
| K990552 | IMMUNOGLOBULIN A TEST SYSTEM | Dade Behring, Inc. | 1999-03-25 |
| K990553 | IGM FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-03-22 |
| K951013 | OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-04-17 |
| K951055 | OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-04-17 |
| K950900 | OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-03-27 |
| K891188 | TITAN GEL IFE TRIVALENT ANTISERUM | Helena Laboratories | 1989-03-22 |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | Atlantic Antibodies | 1989-02-23 |
| K881928 | MONOCLONAL RADIAL IMMUNODIFFUSION KIT | The Binding Site, Ltd. | 1988-07-08 |
| K881828 | IMMUNOGLOBULIN M TEST SYSTEM | The Binding Site, Ltd. | 1988-06-06 |
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