FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
K Number: K884225
·
Decision Dec 9, 1988
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
13
Review Days
64
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Basic Information
- Device Name
- TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
- K Number
- K884225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- A-Kem, Inc.
- Date Received
- October 6, 1988
- Decision Date
- December 9, 1988
- Product Code
- CEK
- 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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEK), ordered by most recent decision date.
HICHEM TOTAL PROTEIN REAGENT
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TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
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CARESIDE TOTAL PROTEIN
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TOTAL PROTEIN OR TP
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CSF/URINE TOTAL PROTEIN
FDA 510(k)
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STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by A-Kem, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884224 | TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS | Dec 15, 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 |
| K873128 | GLUCOSE REAGENT KIT | Oct 23, 1987 | 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 |