ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)
FDA 510(k) clearance K801098 · decided 1980-09-16
Clearance details
- K-number
- K801098
- Device name
- ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)
- Applicant
- Flow Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-09
- Decision date
- 1980-09-16
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- GOL
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RUBELLA ANTIBODY FLUOROIMMUNOASSAY (K841174) | Intl. Diagnostic Technology | 1984-06-07 |
| RUBAQUICK DIAGNOSTIC KIT (K834032) | Abbott Laboratories | 1984-04-17 |
| RUBELLA ANTIBODIES TEST REAGENTS (K810309) | Calbiochem-Behring Corp. | 1981-03-11 |
| RUBELISA IGM TEST KIT (K802508) | M.A. Bioproducts | 1980-12-18 |
| RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (K802102) | Calbiochem-Behring Corp. | 1980-12-18 |
| EIA RUBELLA-G (K802339) | Beckman Instruments, Inc. | 1980-12-18 |
| GAMMA COAT(125 I) RUBELLA ANTIBODY (K801667) | Clinical Assays, Inc. | 1980-10-23 |
| ANTIGEN CONTROL CELLS (K801507) | Ortho Diagnostics, Inc. | 1980-08-20 |
| RUBELLA BIO-BEAD TITRATION KIT (K800789) | Litton Bionetics | 1980-06-30 |
| MACRO-VUE RUBELLA CARD TEST (K800797) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-06-20 |
| FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD (K792249) | Intl. Diagnostic Technology | 1980-01-23 |
| RUBELLA BIO-BEAD SCREEN KIT (K791610) | Litton Bionetics | 1979-11-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 3M BRAND MICROBIAL PROFILE SYSTEM (N50538/S001) | Flow Laboratories, Inc. | 1981-04-17 |
| FLOW MIC SYSTEM (N50538) | Flow Laboratories, Inc. | 1980-07-15 |