American Monitor Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
73
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K895999PHOSPHORUSJanuary 11, 1990
K896000ASPARTATE AMINOTRANFERASE (AST)January 11, 1990
K896001ALANINE AMINOTRANSFERASE (ALT)November 13, 1989
K895423ACCESS CHEMISTRY ANALYZEROctober 4, 1989
K893137EXCEL (TM) CHEMISTRY ANALYZERAugust 10, 1989
K892331ENZYMATIC UREA NITROGEN REAGENT SETJune 20, 1989
K893479CHOLESTEROL REAGENT SETJune 19, 1989
K892002NEOCHROME(R) III GLUCOSEJune 12, 1989
K890312GAMMA-GLUTAMYLTRANSFERASEMarch 24, 1989
K890034PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)February 3, 1989
K883504DURAZYME(R) CPKSeptember 13, 1988
K882497ENZYMATIC CO2 REAGENT SETAugust 2, 1988
K873074SODIUM AND POTASSIUM BY ION SELECTIVEOctober 20, 1987
K872073BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052September 11, 1987
K872181ETHANOL CALIBRATORJuly 21, 1987
K872180KINETIC 610 ETHANOLJuly 7, 1987
K871301ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHODApril 22, 1987
K870277MONITORX LASERX THEOPHYLLINE REAGENT SETFebruary 18, 1987
K862963THERAPEUTIC DRUG MONITORING CONTROL SETSeptember 15, 1986
K862964ANTIASTHMATIC CALIBRATORSAugust 19, 1986