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Leeco Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
49
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K895765LEECO PREVIEW(R) EBV (EIA)October 31, 1989
K894122LEECO VIS-DISK STREP-A (EIA)August 15, 1989
K891095VIS-DISK HCG (EIA) LYOPHILIZED JPL-044MJune 16, 1989
K891096VIS-DISK HCG (EIA) JPL-041MJune 16, 1989
K883269PRL-QUANTSeptember 13, 1988
K880577CONCEP-7-BHCGMarch 15, 1988
K880069LEECO PREGNASTICK (EIA) CATALOG #003February 11, 1988
K870259VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044March 10, 1987
K864170LEECO VIS-CUBE STREP A (EIA)February 3, 1987
K863999VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042January 9, 1987
K863933VIS-CUBE HCG (EIA)December 15, 1986
K861354RIGHT-DAY OVULATION HOME TESTSeptember 16, 1986
K861703LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)July 29, 1986
K860538RIGHT-DAY URINARY LH (EIA)July 29, 1986
K861945LEE-BEAD PROLACTIN (EIA)June 13, 1986
K860947LEECO-SCREEN, STREP A (EIA)May 13, 1986
K860003LEECO TESTOSTERONE DIAGNOSTIC KITMarch 17, 1986
K854837LEE-BEAD BETA FSH (EIA)January 13, 1986
K854838LEE-BEAD BETA LH (EIA)January 7, 1986
K853977BETA-TSH-IRMAOctober 22, 1985