FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
K Number: K053090
·
Decision Dec 16, 2005
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
270
Review Days
44
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Basic Information
- Device Name
- DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
- K Number
- K053090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- November 2, 2005
- Decision Date
- December 16, 2005
- Product Code
- JFM
- 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 |
|---|---|---|---|
| JFM | Enzymatic Method, Bilirubin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFM), ordered by most recent decision date.
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WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
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·Clinical Chemistry
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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