FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
K Number: K950308
·
Decision Apr 14, 1995
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
1
Applicant Total
28
Review Days
79
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Basic Information
- Device Name
- STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
- K Number
- K950308
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3540
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Solarcare Technologies Corp,Inc.
- Date Received
- January 25, 1995
- Decision Date
- April 14, 1995
- Product Code
- JXS
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| JXS | Block, Cutting, Ent, Sterile | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXS), ordered by most recent decision date.
View allOther 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 |
| K954266 | STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY | Oct 13, 1995 | Substantially Equivalent |
| K935573 | AMPHETAMINES MICRO-PLATE EIA | Jul 14, 1995 | Substantially Equivalent |
| K935565 | OPIATES MICRO-PLATE ASSAY | Jul 14, 1995 | Substantially Equivalent |
| K944056 | AUTO-LYTE METHADONE DIA | Dec 29, 1994 | Substantially Equivalent |