FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
K Number: K151487
·
Decision Jan 14, 2016
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
144
Applicant Total
3
Review Days
226
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
- Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
- K Number
- K151487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diatron U.S., Inc.
- Date Received
- June 2, 2015
- Decision Date
- January 14, 2016
- Product Code
- CFR
- 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFR), ordered by most recent decision date.
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Glucose2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry