FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALPHA URINE SAMPLE
K Number: K900626
·
Decision Mar 6, 1990
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
5
Review Days
26
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
- ALPHA URINE SAMPLE
- K Number
- K900626
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Toxi-Lab, Inc.
- Date Received
- February 8, 1990
- Decision Date
- March 6, 1990
- Product Code
- DIF
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIF), ordered by most recent decision date.
Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
FDA 510(k)
FDA Class 1
·Clinical Toxicology
MULTICHEM WBT
FDA 510(k)
FDA Class 1
·Clinical Toxicology
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
FDA 510(k)
FDA Class 1
·Clinical Toxicology