COMINED STANDARD SOLUTION
FDA 510(k) clearance K130100 · decided 2013-04-18
Clearance details
- K-number
- K130100
- Device name
- COMINED STANDARD SOLUTION
- Applicant
- Mesa Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-15
- Decision date
- 2013-04-18
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- FKH
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, 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 |
|---|---|---|
| TDS Standard Solution (K191496) | Mesa Laboratories, Inc. | 2019-08-05 |
| H&S-CONDUCTIVITY STANDARD SOLUTION (K041636) | H & S Technical Services | 2004-07-02 |
| CONDUCTIVITY/TDS CALIBRATOR SOLUTION (K033330) | Mesa Laboratories, Inc. | 2004-02-27 |
| CONDUCTIVITY STANDARD SOLUTION-METERCARE (K032075) | Ibp Instruments GmbH | 2003-09-17 |
| SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (K863824) | D.R.G. Scientific Industries | 1986-10-24 |
| STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF (K851362) | Rna Medical Corp. | 1985-06-12 |
| HEMODIALYSIS VENOUS & ARTERIAL SET (K812622) | Amisco Trading Corp. | 1981-09-24 |
Recalls involving this device
No recalls on record reference this clearance.