FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HemosIL ReadiPlasTin
K Number: K213426
·
Decision Aug 16, 2022
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
321
Review Days
299
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Basic Information
- Device Name
- HemosIL ReadiPlasTin
- K Number
- K213426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory CO
- Date Received
- October 21, 2021
- Decision Date
- August 16, 2022
- Product Code
- GJS
- 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 |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
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Other Clearances by Instrumentation Laboratory CO
| K Number | Device Name | ||
|---|---|---|---|
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Sep 29, 2023 | Substantially Equivalent |
| K223187 | HemosIL Liquid Anti-Xa | Jun 23, 2023 | Substantially Equivalent |
| K223090 | GEM Premier ChemSTAT | Jan 27, 2023 | Substantially Equivalent |
| K223402 | HemosIL von Willebrand Factor Antigen | Dec 9, 2022 | Substantially Equivalent |
| K213464 | HemosIL Liquid Anti-Xa | Oct 4, 2022 | Substantially Equivalent |
| K203790 | GEM Premier 5000 | Aug 20, 2021 | Substantially Equivalent |
| DEN190032 | HemosIL Liquid Anti-Xa | Sep 17, 2020 | Unknown |
| K200033 | HemosIL von Willebrand Factor Antigen | Aug 19, 2020 | Substantially Equivalent |
| K183549 | GEM Premier ChemSTAT | Feb 16, 2019 | Substantially Equivalent |
| K183555 | GEM Premier ChemSTAT | Feb 16, 2019 | Substantially Equivalent |