SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION— 510(k) K935588
Substantially EquivalentSudormed, Inc.
FDA 510(k) clearance K935588 for SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION, Substantially Equivalent on 1995-07-14. Applicant: Sudormed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sudormed, Inc.
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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More clearances from Sudormed, Inc.
view all- K936135 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION
- K936240 — SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
- K926253 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE
- K935564 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION
- K902442 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.