510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Drug Free Enterprises

West Los Angeles, CA, US

Drug Free Enterprises appears in FDA device records in West Los Angeles, CA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
6
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Drug Free Enterprises in 2001.

Clearances by year, as a table
510(k) clearance decisions for Drug Free Enterprises, by decision year
YearClearances
20011
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K012390NO STEP ON SITE DEUG TEST CUPLDJSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0239-04DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.Lacks professional use labeling and firm name and address.Terminated
Z-1256-03DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/MTD Product Code 60925Label lacks professional use legend and name and address of the manufacturer.Terminated
Z-1254-03DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/TCA Product Code 60900Label lacks professional use legend and name and address of the manufacturer.Terminated
Z-1253-03DrugCheck 8 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP Product Code 60800Label lacks professional use legend and name and address of the manufacturer.Terminated
Z-1246-03Drug Check 4 Test Cup AMP/COC/OPI/THC Product Code 60400, and 60410Label lacks professional use legend and name and address of the manufacturer.Terminated
Z-1245-03DrugCheck 3 Test Cup COC/MET/THC Product Code 60300Label lacks professional use legend and name and address of the manufacturer.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain