FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRYASOL ACID CONCENTRATE MIX
K Number: K993212
·
Decision Oct 22, 1999
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
120
Applicant Total
10
Review Days
28
Basic Information
- Device Name
- DRYASOL ACID CONCENTRATE MIX
- K Number
- K993212
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DIASOL, INC.
- Date Received
- September 24, 1999
- Decision Date
- October 22, 1999
- Product Code
- KPO
- 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 |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPO), ordered by most recent decision date.
Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
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HemoCare Bicarbonate Concentrate Set (BCS)
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pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
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FDA Class 2
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NxStage PureFlow Solution
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FDA Class 2
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pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
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FDA Class 2
·Gastroenterology, Urology
Citric Complete Liquid Citric Acid Concentrate
FDA 510(k)
FDA Class 2
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Other Clearances by DIASOL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K130511 | CITRISOL ACID CONCENTRATE | Feb 10, 2014 | Substantially Equivalent |
| K020231 | DIASOL-ADDITIVES | Oct 21, 2002 | Substantially Equivalent |
| K020230 | DIASOL-BICARB | Apr 23, 2002 | Substantially Equivalent |
| K011004 | NEEDLELOK HYPODERMIC NEEDLE PROTECTION | May 24, 2001 | Substantially Equivalent |
| K010958 | FISTULOK FISTULA NEEDLE PROTECTION | May 18, 2001 | Substantially Equivalent |
| K011003 | SAFESTING AND SAFESTING HUB | Apr 20, 2001 | Substantially Equivalent |
| K993187 | SHELLY PROTECTED AV FISTULA NEEDLE | Nov 5, 1999 | Substantially Equivalent |
| K992999 | DAISY PROTECTED SCALP VEIN SET | Nov 5, 1999 | Substantially Equivalent |
| K992653 | SHELLY PROTECTED AV FISTULA NEEDLE | Oct 27, 1999 | Substantially Equivalent |