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Pb Diagnostic Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K940507OPUS FT4 TEST SYSTEMJuly 28, 1994
K934762OPUS PROCAINAMIDE TEST SYSTEMJuly 20, 1994
K933389OPUS CMV-GJune 28, 1994
K934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONMarch 7, 1994
K935229OPUS DIGITOXINDecember 22, 1993
K934705OPUS NAPANovember 22, 1993
K933675OPUS TOTAL CKSeptember 8, 1993
K933066OPUS ESTRADIOLSeptember 8, 1993
K932279OPUS(R) TOTAL B-HCG TEST SYSTEMJuly 8, 1993
K926131OPUS MAGNUM ANALYZERJune 7, 1993
K924957OPUS(R) VANCOMYCINDecember 11, 1992
K924429OPUS(R) CK-MBOctober 15, 1992
K915838OPUS FERRITIN TEST SYSTEMMarch 18, 1992
K915850OPUS MYOGLOBIN TEST SYSTEMMarch 17, 1992
K913938OPUS(R) LH TEST SYSTEMNovember 7, 1991
K913295OPUS(R) PLUS ANALYZERSeptember 11, 1991
K913280OPUS(R) PROLACTIN TEST SYSTEMAugust 16, 1991
K911834OPUS(R) ROZOAugust 12, 1991
K911940OPUS(R) TOBRAMYCINJuly 1, 1991
K905257OPUS CMV TEST SYSTEMApril 17, 1991