FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Amylase2
K Number: K210633
·
Decision May 26, 2022
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
98
Applicant Total
8
Review Days
449
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Basic Information
- Device Name
- Amylase2
- K Number
- K210633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Ireland Diagnostics Division
- Date Received
- March 3, 2021
- Decision Date
- May 26, 2022
- Product Code
- JFJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JFJ | Catalytic Methods, Amylase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFJ), ordered by most recent decision date.
Atellica CH Amylase_2 (AMY_2)
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HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
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ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
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FDA Class 2
·Clinical Chemistry
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
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FDA Class 2
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EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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|---|---|---|---|
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| K203771 | Urea Nitrogen2 | May 31, 2022 | Substantially Equivalent |
| K210452 | Creatinine2 | Mar 22, 2022 | Substantially Equivalent |
| K203530 | Albumin BCP2 | Mar 18, 2022 | Substantially Equivalent |
| K203248 | Albumin BCG2 | Nov 23, 2021 | Substantially Equivalent |