FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
K Number: K800674
·
Decision May 28, 1980
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
26
Review Days
63
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Basic Information
- Device Name
- SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
- K Number
- K800674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Solutions, Inc.
- Date Received
- March 26, 1980
- Decision Date
- May 28, 1980
- 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
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARESIDE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN OR TP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CSF/URINE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Diagnostic Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934892 | RELIEF PLUS ONE REAGENT STRIP MODIFICATION | Jan 11, 1994 | Substantially Equivalent |
| K924398 | UNI-CHECK REAGENT STRIP | Dec 23, 1992 | Substantially Equivalent |
| K921825 | QUICK-CHECK II REAGENT STRIP | Aug 18, 1992 | Substantially Equivalent |
| K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- | May 30, 1980 | Substantially Equivalent |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | May 30, 1980 | Substantially Equivalent |
| K800672 | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC | May 28, 1980 | Substantially Equivalent |
| K800687 | REAGENT FOR DETERM. GLUCOSE IN H/SERUM | May 28, 1980 | Substantially Equivalent |
| K800679 | REAGENTS FOR DETERM. ALKALINE PHOSPHATAS | May 28, 1980 | Substantially Equivalent |
| K800685 | REAGENT FOR DETERM. CREATININE IN H/SERU | May 28, 1980 | Substantially Equivalent |
| K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN | May 28, 1980 | Substantially Equivalent |