Amedica Biotech, Inc.
Hayward, CA, US
Amedica Biotech, Inc. appears in FDA device records in Hayward, CA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Amedica Biotech, Inc. between 2002 and 2010. The busiest year on record is 2002, with 6. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 6 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 2 |
| 2008 | 2 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100108 | AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA | NGL | Substantially Equivalent | |
| K082898 | AMEDICA DRUG SCREEN TEST CUP | NGL | Substantially Equivalent | |
| K080872 | AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ | LDJ | Substantially Equivalent | |
| K063379 | AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 | DKZ | Substantially Equivalent | |
| K061556 | AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 | LDJ | Substantially Equivalent | |
| K040464 | AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST | LDJ | Substantially Equivalent | |
| K031497 | AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST | DJC | Substantially Equivalent | |
| K023109 | AMEDICA DRUG SCREEN PHENCYCLIDINE TEST | LCM | Substantially Equivalent | |
| K023104 | AMEDICA DRUG SCREEN AMPHETAMINE TEST | DKZ | Substantially Equivalent | |
| K023101 | AMEDICA DRUG SCREEN METHAPHETAMINE TEST | LAF | Substantially Equivalent | |
| K023047 | AMEDICA DRUG SCREEN OPIATES TEST | DJG | Substantially Equivalent | |
| K022955 | AMEDICA DRUG SCREEN THC TEST | LDJ | Substantially Equivalent | |
| K022954 | AMEDICA DRUG SCREEN COCAINE TEST | DIO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DKZEnzyme Immunoassay, Amphetamine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LAFGas Chromatography, Methamphetamine
- NGLTest, Opiates, Over The Counter
- DJCThin Layer Chromatography, Methamphetamine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain