FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
K Number: K100108
·
Decision Apr 14, 2010
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
22
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
- K Number
- K100108
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Amedica Biotech, Inc.
- Date Received
- January 14, 2010
- Decision Date
- April 14, 2010
- Product Code
- NGL
- 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 |
|---|---|---|---|
| NGL | Test, Opiates, Over The Counter | FDA class 2 | Clinical Toxicology |
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Other Clearances by Amedica Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K040464 | AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST | May 17, 2004 | 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 |