FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
hemochroma PLUS System
K Number: K182298
·
Decision Nov 16, 2018
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
38
Applicant Total
14
Review Days
84
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Basic Information
- Device Name
- hemochroma PLUS System
- K Number
- K182298
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5620
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunostics Inc.,
- Date Received
- August 24, 2018
- Decision Date
- November 16, 2018
- Product Code
- GKR
- 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 |
|---|---|---|---|
| GKR | System, Hemoglobin, Automated | FDA class 2 | Hematology |
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| K102664 | HEMA SCREEN ER | Jan 28, 2011 | Substantially Equivalent |
| K060463 | HEMA SCREEN SPECIFIC IFOBT | Jun 6, 2006 | Substantially Equivalent |
| K041728 | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE | Aug 11, 2004 | Substantially Equivalent |
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