FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPEC(TM) EXTRACTION CARTRIDGE
K Number: K901694
·
Decision Jun 1, 1990
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
11
Applicant Total
5
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SPEC(TM) EXTRACTION CARTRIDGE
- K Number
- K901694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Toxi-Lab, Inc.
- Date Received
- April 10, 1990
- Decision Date
- June 1, 1990
- Product Code
- DKE
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DKE | Reagents, Test, Tetrahydrocannabinol | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKE), ordered by most recent decision date.
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STATUS STIK, ACCUSIGN STIK
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STATUS CUP ACCUSIGN CUP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
FDA 510(k)
FDA Class 2
·Clinical Toxicology