FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
K Number: K192730
·
Decision Sep 9, 2020
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
4
Review Days
348
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Basic Information
- Device Name
- CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
- K Number
- K192730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biosystems S.A.
- Date Received
- September 27, 2019
- Decision Date
- September 9, 2020
- Product Code
- CHW
- 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 |
|---|---|---|---|
| CHW | Titrimetric With Edta And Indicator, Calcium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Biosystems S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K190495 | Transferrin | Mar 16, 2020 | Substantially Equivalent |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | May 2, 2019 | Substantially Equivalent |
| K170901 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 | Apr 13, 2018 | Substantially Equivalent |