FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LYSIS +
K Number: K830186
·
Decision Feb 28, 1983
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
14
Review Days
40
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Basic Information
- Device Name
- LYSIS +
- K Number
- K830186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8540
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Hematology Marketing Assoc.
- Date Received
- January 19, 1983
- Decision Date
- February 28, 1983
- Product Code
- GGK
- 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 |
|---|---|---|---|
| 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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FDA 510(k)
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Other Clearances by Hematology Marketing Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K851843 | OSMOCEL 3 | Jul 30, 1985 | Substantially Equivalent |
| K851375 | TRI-COUNT | Jul 12, 1985 | Substantially Equivalent |
| K850096 | LASER-GLOBIN | Mar 29, 1985 | Substantially Equivalent |
| K850095 | LASER-DIL | Mar 29, 1985 | Substantially Equivalent |
| K850097 | LASER-LYSE | Mar 29, 1985 | Substantially Equivalent |
| K850094 | LASER-GLOBIN POWDER | Mar 29, 1985 | Substantially Equivalent |
| K844708 | TRI-COUNT CALIBRATOR | Mar 5, 1985 | Substantially Equivalent |
| K843485 | TRI-COUNT LASER | Dec 12, 1984 | Substantially Equivalent |
| K834371 | TRI-COUNT 10 | Mar 9, 1984 | Substantially Equivalent |
| K833130 | TRI-COUNT 7 | Oct 20, 1983 | Substantially Equivalent |