SYSTEM 6000 AUTOMATED RIA ANALYZER
FDA 510(k) clearance K780886 · decided 1978-09-01
Clearance details
- K-number
- K780886
- Device name
- SYSTEM 6000 AUTOMATED RIA ANALYZER
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-05-26
- Decision date
- 1978-09-01
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- LCI
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| 25-HYDROXYVITAMIN D 125I RIA KIT (K983617) | DiaSorin, Inc. | 1998-11-16 |
| CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA (K801037) | Union Carbide Corp. | 1980-05-28 |
Recalls involving this device
No recalls on record reference this clearance.