510(k) K951013
- Device
- Olympus Igg Immunoturbidimetric Reagent
- Applicant
- OLYMPUS AMERICA, INC.
- 510(k) number
- K951013
- Product code
- CFQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-17
- Date received
- 1995-03-06
- Regulation
- 866.5510
- Classification name
- Radioimmunoassay, Immunoglobulins (G, A, M)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAURA STORMS-TYLER
- Address
- 4 Nevada Dr. Lake Success NY US 11042 11042
FDA Registration Numbers#
- 3006198300
- 3005360469
- 3003601075
- 3010825766
- 2020726
- 9610806
- 2517506
- 1618982
- 1319436
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 |
| 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 |
| K881827 | IMMUNOGLOBULIN A TEST SYSTEM | The Binding Site, Ltd. | 1988-06-10 |
| K881828 | IMMUNOGLOBULIN M TEST SYSTEM | The Binding Site, Ltd. | 1988-06-06 |