FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE REAGENT KIT
K Number: K873128
·
Decision Oct 23, 1987
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
13
Review Days
74
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Basic Information
- Device Name
- GLUCOSE REAGENT KIT
- K Number
- K873128
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- A-Kem, Inc.
- Date Received
- August 10, 1987
- Decision Date
- October 23, 1987
- 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 |
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Other Clearances by A-Kem, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884224 | TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS | Dec 15, 1988 | Substantially Equivalent |
| K884225 | TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS | Dec 9, 1988 | Substantially Equivalent |
| K884226 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | Dec 9, 1988 | Substantially Equivalent |
| K884227 | CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM | Dec 9, 1988 | Substantially Equivalent |
| K882587 | A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM | Aug 8, 1988 | Substantially Equivalent |
| K882586 | A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM | Aug 8, 1988 | Substantially Equivalent |
| K873129 | CARBON DIOXIDE REAGENT KIT | Oct 23, 1987 | Substantially Equivalent |
| K873127 | CHLORIDE REAGENT KIT | Oct 23, 1987 | Substantially Equivalent |
| K873131 | CREATININE REAGENT KIT | Oct 23, 1987 | Substantially Equivalent |
| K873130 | WASH SOLUTION KIT | Oct 23, 1987 | Substantially Equivalent |