FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
K Number: K974699
·
Decision Jan 22, 1998
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
93
Applicant Total
20
Review Days
37
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
- REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
- K Number
- K974699
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Consolidated Technologies, Inc.
- Date Received
- December 16, 1997
- Decision Date
- January 22, 1998
- Product Code
- DKB
- 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 |
|---|---|---|---|
| DKB | Calibrators, Drug Mixture | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKB), ordered by most recent decision date.
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RANDOX METHAMPHETAMINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Consolidated Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000116 | QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 | Feb 15, 2000 | Substantially Equivalent |
| K992578 | URINE CHEMISTRY CONTROL, LEVEL 2 | Sep 3, 1999 | Substantially Equivalent |
| K992576 | URINE CHEMISTRY CONTROL, LEVEL 1 | Sep 3, 1999 | Substantially Equivalent |
| K992151 | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE | Jul 14, 1999 | Substantially Equivalent |
| K981339 | QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 | Apr 21, 1998 | Substantially Equivalent |
| K973469 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS | Sep 25, 1997 | Substantially Equivalent |
| K972146 | QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS | Jul 8, 1997 | Substantially Equivalent |
| K972080 | QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 | Jun 18, 1997 | Substantially Equivalent |
| K961815 | QUALITROL ANA CONTROL SERUM SET | Sep 27, 1996 | Substantially Equivalent |
| K961550 | QUALITROL MONO CONTROL SERUM SET | Sep 24, 1996 | Substantially Equivalent |