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Electro-Nucleonics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K893718DELTATEST (R) LIPASE IISeptember 28, 1989
K883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIApril 28, 1989
K883282VIRGO HSV-1 IGG ELISAMarch 10, 1989
K883427VIRGO(R) VZV-IGG ELISAMarch 10, 1989
K883281VIRGO HSV-2 IGG ELISAMarch 10, 1989
K883102VIRGO (R) CMV-IGG ELISAFebruary 8, 1989
K884784VIRGO(R) MICROWELL ALT ASSAYDecember 29, 1988
K883205ALTLTS ALANINE AMINO TRANSFERASE ALTSeptember 9, 1988
K883206LACTATE DEHYDROGENASE LDHSeptember 9, 1988