CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA
FDA 510(k) clearance K801037 · decided 1980-05-28
Clearance details
- K-number
- K801037
- Device name
- CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA
- Applicant
- Union Carbide Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-02
- Decision date
- 1980-05-28
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- LCI
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, 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 |
| SYSTEM 6000 AUTOMATED RIA ANALYZER (K780886) | Beckman Instruments, Inc. | 1978-09-01 |
Recalls involving this device
No recalls on record reference this clearance.