510(k) K831811
- Device
- REVOLUTION RADIAL IMMUNODIFFUSION PLATE
- Applicant
- CALBIOCHEM-BEHRING CORP.
- 510(k) number
- K831811
- Product code
- JZQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-07-28
- Date received
- 1983-06-06
- Regulation
- 866.4800
- Classification name
- Plates And Equipment, Radial Immunodiffusion
- 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#
- 3019906
- 1423662
- 1524213
- 3012471076
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JZQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881174 | RID PLATE READER | The Binding Site, Ltd. | 1988-06-08 |
| K881675 | IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS | Dynatech Laboratories, Inc. | 1988-04-21 |
| K792699 | OUCHTERLONY AGAR PLATES | Meridian Diagnostics, Inc. | 1980-01-24 |
| K790646 | HELENA QUIPLATE SYSTEM | Helena Laboratories | 1979-05-23 |
| K770548 | IMMUNOPLATE III RADIO IMMUNODIFFUSION | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-15 |
| K761311 | ACCRAASSAY RID KITS | Miles Laboratories, Inc. | 1976-12-30 |
Legacy Summary#
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FDA Review#
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