FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUCHEK BG.
K Number: K821091
·
Decision May 14, 1982
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
21
Review Days
25
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
- ACCUCHEK BG.
- K Number
- K821091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biodynamics Corp.
- Date Received
- April 19, 1982
- Decision Date
- May 14, 1982
- Product Code
- CGA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGA), ordered by most recent decision date.
ABL90 FLEX PLUS System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
YSI 2900C Biochemistry Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EasyStat 300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cholestech LDX System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT G cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Biodynamics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K051675 | BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER | Mar 16, 2006 | Substantially Equivalent |
| K884033 | BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER | Nov 17, 1988 | Substantially Equivalent |
| K881631 | BIODYNAMICS AUTOTRANSFUSION RESERVOIR | Sep 9, 1988 | Substantially Equivalent |
| K881968 | BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER | Jul 28, 1988 | Substantially Equivalent |
| K874361 | BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER | Mar 16, 1988 | Substantially Equivalent |
| K873807 | AUTOTRANSFUSION APPARATUS | Mar 9, 1988 | Substantially Equivalent |
| K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR | Oct 23, 1987 | Substantially Equivalent |
| K870052 | INFUMIX MIXING CONTAINER | Feb 27, 1987 | Substantially Equivalent |
| K822716 | UNIVERSAL CENTRIFUGE | Sep 30, 1982 | Substantially Equivalent |
| K822715 | PLATELET CENTRIFUGE | Sep 30, 1982 | Substantially Equivalent |