FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARBITURATES
K Number: K012996
·
Decision Mar 20, 2002
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
99
Applicant Total
883
Review Days
195
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
- BARBITURATES
- K Number
- K012996
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- September 6, 2001
- Decision Date
- March 20, 2002
- Product Code
- DIS
- 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 |
|---|---|---|---|
| DIS | Enzyme Immunoassay, Barbiturate | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIS), ordered by most recent decision date.
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CR3 Keyless Split Sample Cup Secobarbital- Methadone
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GenPrime Snap-Top Split Key Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Abbott Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252424 | Anti-HCV Next | Apr 28, 2026 | Substantially Equivalent |
| K243500 | ARCHITECT iGentamicin | Jul 9, 2025 | Substantially Equivalent |
| K243168 | Alinity i Rubella IgG | Jun 20, 2025 | Substantially Equivalent |
| K243283 | Alinity h-series System | Feb 20, 2025 | Substantially Equivalent |
| K233932 | Alinity i Toxo IgM | Aug 30, 2024 | Substantially Equivalent |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent |
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K220031 | Alinity h-series System | Aug 4, 2023 | Substantially Equivalent |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Jul 14, 2023 | Substantially Equivalent |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Jun 5, 2023 | Substantially Equivalent |