510(k) K800797
- Device
- Macro-vue Rubella Card Test
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K800797
- Product code
- GOL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-06-20
- Date received
- 1980-04-09
- Regulation
- 866.3510
- Classification name
- Antigen, Ha (Including Ha Control), Rubella
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GOL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K841174 | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | Intl. Diagnostic Technology | 1984-06-07 |
| K834032 | RUBAQUICK DIAGNOSTIC KIT | Abbott Laboratories | 1984-04-17 |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Calbiochem-Behring Corp. | 1981-03-11 |
| K802508 | RUBELISA IGM TEST KIT | M.A. Bioproducts | 1980-12-18 |
| K802339 | EIA RUBELLA-G | Beckman Instruments, Inc. | 1980-12-18 |
| K802102 | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI | Calbiochem-Behring Corp. | 1980-12-18 |
| K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY | Clinical Assays, Inc. | 1980-10-23 |
| K801098 | ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) | Flow Laboratories, Inc. | 1980-09-16 |
| K801507 | ANTIGEN CONTROL CELLS | Ortho Diagnostics, Inc. | 1980-08-20 |
| K800789 | RUBELLA BIO-BEAD TITRATION KIT | Litton Bionetics | 1980-06-30 |
| K792249 | FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD | Intl. Diagnostic Technology | 1980-01-23 |
| K791610 | RUBELLA BIO-BEAD SCREEN KIT | Litton Bionetics | 1979-11-13 |
| K790976 | RUBAZYME | Abbott Laboratories | 1979-08-16 |
| K790212 | CORDIA T | Cordis Corp. | 1979-04-12 |
| K780885 | CORDIA R | Cordis Corp. | 1979-01-17 |