FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE AUTO& STAT GA-1120
K Number: K843003
·
Decision Sep 28, 1984
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
11
Review Days
60
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Basic Information
- Device Name
- GLUCOSE AUTO& STAT GA-1120
- K Number
- K843003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Kyoto Diagnostics, Inc.
- Date Received
- July 30, 1984
- Decision Date
- September 28, 1984
- Product Code
- CGA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
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Other Clearances by Kyoto Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861733 | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS | Jul 25, 1986 | Substantially Equivalent |
| K842750 | OSMOTIC PRESSURE AUTO & STAT OM-6010 | Aug 17, 1984 | Substantially Equivalent |
| K842168 | ATAGO URINE SPECIFIC GRAVITY & SERUM | Jul 16, 1984 | Substantially Equivalent |
| K841715 | KYOTEST UK URINE TEST REAGENT STRIP | May 31, 1984 | Substantially Equivalent |
| K841713 | KYOTEST UG URINE TEST REAGENT STRIP | May 31, 1984 | Substantially Equivalent |
| K841714 | KYOTEST 2V, URINE TEST REAGENT STRIP | May 31, 1984 | Substantially Equivalent |
| K840828 | KYOTEST 8V | May 14, 1984 | Substantially Equivalent |
| K840827 | KYOTEST 5V | May 14, 1984 | Substantially Equivalent |
| K840996 | URINE ANALYZER SYSTEM | May 1, 1984 | Substantially Equivalent |
| K840829 | KYOTEST UGK | Apr 19, 1984 | Substantially Equivalent |