FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACID FUCHSIN SOLUTIONS
K Number: K870889
·
Decision Jul 8, 1987
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
60
Applicant Total
5
Review Days
125
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Basic Information
- Device Name
- ACID FUCHSIN SOLUTIONS
- K Number
- K870889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- D.R.G. Scientific Industries
- Date Received
- March 5, 1987
- Decision Date
- July 8, 1987
- Product Code
- FKQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FKQ | System, Dialysate Delivery, Central Multiple Patient | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by D.R.G. Scientific Industries
| K Number | Device Name | ||
|---|---|---|---|
| K892329 | OSMOMETER STANDARD SOLUTIONS | Oct 31, 1989 | Substantially Equivalent |
| K863880 | BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. | Nov 24, 1986 | Substantially Equivalent |
| K863825 | CO-OXIMETER SOLUTIONS | Nov 24, 1986 | Substantially Equivalent |
| K863824 | SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. | Oct 24, 1986 | Substantially Equivalent |