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DJG

215 FDA 510(k) clearances · Product code

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RecordFirmDate
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE (K882496)Roche Diagnostic Systems, Inc.1988-09-02
EMIT HVA OPIATE ASSAY (K881941)Syva Co.1988-08-02
COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 (K874808)Diagnostic Products Corp.1988-02-18
REVISED LABELING FOR ADX OPIATES (K880010)Abbott Laboratories1988-02-11
REVISED LABELING FOR OPIATES (K874485)Abbott Laboratories1987-11-23
REVISED LABELING FOR MORPHINE TEST KIT (K874268)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR SYVA OPIATE ASSAYS (K873898)Syva Co.1987-10-29
LABELING CHANGE COAT-A-COUNT SERUM MORPHINE (K873758)Diagnostic Products Corp.1987-10-15
LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE (K873757)Diagnostic Products Corp.1987-10-15
ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD (K872391)E.I. Dupont DE Nemours & Co., Inc.1987-08-10
RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] (K871698)Immunalysis Corporation1987-06-15
TDX R OPIATES (K854421)Abbott Laboratories1985-11-25
EMIT D.A.U. OPIATE ASSAY (K842677)Syva Co.1984-09-26
EMIT 700 OPIATE ASSAY (K843162)Syva Co.1984-09-14
MODIF. OF EMIT URINE OPIATE ASSAY (K833581)Syva Co.1984-01-26
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