FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LYSING & HEMOGLOBIN S-REAGENT J & S
K Number: K833444
·
Decision Nov 3, 1983
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
2
Review Days
29
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Basic Information
- Device Name
- LYSING & HEMOGLOBIN S-REAGENT J & S
- K Number
- K833444
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8540
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Jasins & Sayles Associates, Inc.
- Date Received
- October 5, 1983
- Decision Date
- November 3, 1983
- Product Code
- GGK
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GGK), ordered by most recent decision date.
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Other Clearances by Jasins & Sayles Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K833443 | ISOTONIC BLOOD CELL DILUENT J & S | Nov 3, 1983 | Substantially Equivalent |