FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
K Number: K954266
·
Decision Oct 13, 1995
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
28
Review Days
31
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Basic Information
- Device Name
- STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
- K Number
- K954266
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Solarcare Technologies Corp,Inc.
- Date Received
- September 12, 1995
- Decision Date
- October 13, 1995
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
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Other Clearances by Solarcare Technologies Corp,Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954326 | STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY | Jul 23, 1996 | Substantially Equivalent |
| K954156 | STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY | Jul 22, 1996 | Substantially Equivalent |
| K955905 | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | May 30, 1996 | Substantially Equivalent |
| K954158 | STC DIAGNOSTICS AUTO-LYTE PH ASSAY | Apr 30, 1996 | Substantially Equivalent |
| K940048 | STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION | Mar 19, 1996 | Substantially Equivalent |
| K954073 | STC DIAGNOSTICS LSD MICRO-PLATE EIA | Nov 29, 1995 | Substantially Equivalent |
| K935573 | AMPHETAMINES MICRO-PLATE EIA | Jul 14, 1995 | Substantially Equivalent |
| K935565 | OPIATES MICRO-PLATE ASSAY | Jul 14, 1995 | Substantially Equivalent |
| K950308 | STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA | Apr 14, 1995 | Substantially Equivalent |
| K944056 | AUTO-LYTE METHADONE DIA | Dec 29, 1994 | Substantially Equivalent |