FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST
K Number: K040464
·
Decision May 17, 2004
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
149
Applicant Total
13
Review Days
84
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
- AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST
- K Number
- K040464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Amedica Biotech, Inc.
- Date Received
- February 23, 2004
- Decision Date
- May 17, 2004
- Product Code
- LDJ
- 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 |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDJ), ordered by most recent decision date.
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Amedica Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100108 | AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA | Apr 14, 2010 | Substantially Equivalent |
| K082898 | AMEDICA DRUG SCREEN TEST CUP | Dec 19, 2008 | Substantially Equivalent |
| K080872 | AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ | Aug 19, 2008 | Substantially Equivalent |
| K063379 | AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 | Dec 11, 2006 | Substantially Equivalent |
| K061556 | AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 | Jul 21, 2006 | Substantially Equivalent |
| K031497 | AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST | Oct 17, 2003 | Substantially Equivalent |
| K023109 | AMEDICA DRUG SCREEN PHENCYCLIDINE TEST | Dec 16, 2002 | Substantially Equivalent |
| K023104 | AMEDICA DRUG SCREEN AMPHETAMINE TEST | Dec 16, 2002 | Substantially Equivalent |
| K023101 | AMEDICA DRUG SCREEN METHAPHETAMINE TEST | Dec 16, 2002 | Substantially Equivalent |
| K023047 | AMEDICA DRUG SCREEN OPIATES TEST | Nov 6, 2002 | Substantially Equivalent |