FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANKS' BALANCED SALTS (HBSS) NO. H1387
K Number: K870484
·
Decision Mar 30, 1987
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
16
Applicant Total
231
Review Days
55
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Basic Information
- Device Name
- HANKS' BALANCED SALTS (HBSS) NO. H1387
- K Number
- K870484
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2875
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Sigma Chemical Co.
- Date Received
- February 3, 1987
- Decision Date
- March 30, 1987
- Product Code
- KIP
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KIP | Formulations, Balanced Salt Solutions | FDA class 1 | Hematology |
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| K933679 | SIGMA BUN REAGENT | Dec 17, 1993 | Substantially Equivalent |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Dec 17, 1993 | Substantially Equivalent |
| K933703 | SIGMA WASH CONCENTRATE SOLUTION | Dec 10, 1993 | Substantially Equivalent |
| K933692 | SIGMA CO2 ACID REAGENT | Dec 9, 1993 | Substantially Equivalent |
| K933695 | SIGMA ELECTROLYTE BUFFER | Oct 22, 1993 | Substantially Equivalent |
| K933697 | SIGMA CRE REAGENT | Oct 18, 1993 | Substantially Equivalent |
| K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 | Oct 13, 1993 | Substantially Equivalent |