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FDA 510(k) Applications Submitted by ORGENTEC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K960274
01/19/1996
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY
ORGENTEC
K954814
10/19/1995
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
ORGENTEC
K954815
10/19/1995
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
ORGENTEC
K954829
10/20/1995
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
ORGENTEC
K954830
10/20/1995
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
ORGENTEC
K954831
10/20/1995
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
ORGENTEC
K954832
10/20/1995
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
ORGENTEC
K955133
11/09/1995
ORGENTEC ENASCREEN PIN IMMUNO ASSAY
ORGENTEC
K955134
11/09/1995
ORGENTEC ENASCREEN ELISA ASSAY
ORGENTEC
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