SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.
FDA 510(k) clearance K863824 · decided 1986-10-24
Clearance details
- K-number
- K863824
- Device name
- SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.
- Applicant
- D.R.G. Scientific Industries
- Decision
- Substantially Equivalent
- Date received
- 1986-09-30
- Decision date
- 1986-10-24
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- FKH
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- East Boston, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch D.R.G. Scientific Industries
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| COMINED STANDARD SOLUTION (K130100) | Mesa Laboratories, Inc. | 2013-04-18 |
| 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 |
| 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.