FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SEKURE Creatine Kinase Assay
K Number: K182702
·
Decision Apr 17, 2019
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
122
Applicant Total
6
Review Days
202
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SEKURE Creatine Kinase Assay
- K Number
- K182702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
- Date Received
- September 27, 2018
- Decision Date
- April 17, 2019
- Product Code
- CGS
- 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 |
|---|---|---|---|
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGS), ordered by most recent decision date.
Pointe Scientific Creatinine Kinase (CK) Reagent Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CPK REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Sekisui Diagnostics P.E.I., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202644 | Acetaminophen | Feb 18, 2022 | Substantially Equivalent |
| K180835 | SEKURE Acetaminophen L3K Assay | Feb 8, 2019 | Substantially Equivalent |
| K173206 | SEKURE HbA1c Assay | Jul 12, 2018 | Substantially Equivalent |
| K163078 | DC-UIBC-CAL | Dec 8, 2016 | Substantially Equivalent |
| K111915 | MAGNESIUM ASSAY | Dec 2, 2011 | Substantially Equivalent |