FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARESIDE GLUCOSE
K Number: K981183
·
Decision May 7, 1998
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
9
Review Days
36
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
- CARESIDE GLUCOSE
- K Number
- K981183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exigent Diagnostics, Inc.
- Date Received
- April 1, 1998
- Decision Date
- May 7, 1998
- Product Code
- CGA
- 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 |
|---|---|---|---|
| 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 Exigent Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982118 | CARESIDE ANALYZER | Jul 24, 1998 | Substantially Equivalent |
| K981899 | CARESIDE HDL-CHOLESTEROL | Jul 14, 1998 | Substantially Equivalent |
| K980043 | CARESIDE CREATININE | Mar 30, 1998 | Substantially Equivalent |
| K980056 | CARESIDE ANALYZER | Mar 6, 1998 | Substantially Equivalent |
| K980057 | CARESIDE BUN | Feb 5, 1998 | Substantially Equivalent |
| K980042 | CARESIDE TOTAL PROTEIN | Feb 4, 1998 | Substantially Equivalent |
| K980041 | CARESIDE ALBUMIN | Feb 4, 1998 | Substantially Equivalent |
| K980055 | CARESIDE GLOBULIN | Jan 28, 1998 | Substantially Equivalent |