FDA 510(k) Applications Submitted by Joe Shia
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130055 |
01/09/2013 |
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP |
Guangzhou Wondfo Biotech Co., Ltd. |
| K140089 |
01/14/2014 |
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) |
Guangzhou Wondfo Biotech Co., Ltd. |
| K110182 |
01/21/2011 |
CANNABINOIDS URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
| K140546 |
03/04/2014 |
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST |
HEALGEN SCIENTIFIC, LLC |
| K130665 |
03/12/2013 |
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL |
Guangzhou Wondfo Biotech Co., Ltd. |
| K121166 |
04/17/2012 |
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL |
Guangzhou Wondfo Biotech Co., Ltd. |
| K131232 |
05/01/2013 |
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) |
Guangzhou Wondfo Biotech Co., Ltd. |
| K121557 |
05/25/2012 |
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
| K111560 |
06/03/2011 |
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
| K141532 |
06/10/2014 |
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE |
Guangzhou Wondfo Biotech Co., Ltd. |
| K131754 |
06/14/2013 |
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) |
Guangzhou Wondfo Biotech Co., Ltd. |
| K141647 |
06/19/2014 |
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) |
HEALGEN SCIENTIFIC, LLC |
| K121987 |
07/06/2012 |
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
| K112071 |
07/20/2011 |
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P |
Guangzhou Wondfo Biotech Co., Ltd. |
| K142044 |
07/28/2014 |
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE |
Guangzhou Wondfo Biotech Co., Ltd. |
| K112236 |
08/04/2011 |
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
| K112310 |
08/10/2011 |
WONDFO METHADONE URINE TEST,OPIATE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
| K112395 |
08/19/2011 |
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
| K132630 |
08/22/2013 |
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) |
Guangzhou Wondfo Biotech Co., Ltd. |
| K122904 |
09/21/2012 |
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; |
Guangzhou Wondfo Biotech Co., Ltd. |
| K122961 |
09/25/2012 |
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) |
Guangzhou Wondfo Biotech Co., Ltd. |
| K133343 |
10/30/2013 |
WONDFO RAPID STREP A TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
| K113624 |
12/08/2011 |
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
| K133968 |
12/26/2013 |
WONDFO MULTI-DRUG URINE TEST CUP, PANEL |
Guangzhou Wondfo Biotech Co., Ltd. |
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