510(k) K033330
- Device
- CONDUCTIVITY/TDS CALIBRATOR SOLUTION
- Applicant
- MESA LABORATORIES, INC.
- 510(k) number
- K033330
- Product code
- FKH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-02-27
- Date received
- 2003-10-16
- Regulation
- 876.5820
- Classification name
- Solution-test Standard-conductivity, Dialysis
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TODD ROMERO
- Address
- 12100 W. 6th Ave. Lakewood CO US 80228 80228
FDA Registration Numbers#
- 1720309
- 3003884198
- 2020976
- 3003145976
Source Documents#
Other 510(k) Records For Product Code FKH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191496 | TDS Standard Solution | Mesa Laboratories, Inc. | 2019-08-05 |
| K130100 | COMINED STANDARD SOLUTION | Mesa Laboratories, Inc. | 2013-04-18 |
| K041636 | H&S-CONDUCTIVITY STANDARD SOLUTION | H & S Technical Services | 2004-07-02 |
| K032075 | CONDUCTIVITY STANDARD SOLUTION-METERCARE | Ibp Instruments GmbH | 2003-09-17 |
| K863824 | SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. | D.R.G. Scientific Industries | 1986-10-24 |
| K851362 | STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF | Rna Medical Corp. | 1985-06-12 |
| K812622 | HEMODIALYSIS VENOUS & ARTERIAL SET | Amisco Trading Corp. | 1981-09-24 |
Legacy Summary#
summary
FDA Review#
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