FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEOCHROME II GLUCOSE, #4044
K Number: K792534
·
Decision Jan 16, 1980
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
73
Review Days
40
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
- NEOCHROME II GLUCOSE, #4044
- K Number
- K792534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Monitor Corp.
- Date Received
- December 7, 1979
- Decision Date
- January 16, 1980
- 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 American Monitor Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K895999 | PHOSPHORUS | Jan 11, 1990 | Substantially Equivalent |
| K896000 | ASPARTATE AMINOTRANFERASE (AST) | Jan 11, 1990 | Substantially Equivalent |
| K896001 | ALANINE AMINOTRANSFERASE (ALT) | Nov 13, 1989 | Substantially Equivalent |
| K895423 | ACCESS CHEMISTRY ANALYZER | Oct 4, 1989 | Substantially Equivalent |
| K893137 | EXCEL (TM) CHEMISTRY ANALYZER | Aug 10, 1989 | Substantially Equivalent |
| K892331 | ENZYMATIC UREA NITROGEN REAGENT SET | Jun 20, 1989 | Substantially Equivalent |
| K893479 | CHOLESTEROL REAGENT SET | Jun 19, 1989 | Substantially Equivalent |
| K892002 | NEOCHROME(R) III GLUCOSE | Jun 12, 1989 | Substantially Equivalent |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | Mar 24, 1989 | Substantially Equivalent |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | Feb 3, 1989 | Substantially Equivalent |