Hycel, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K802422HYCEL TRIGYCERIDE II TESTOctober 6, 1980
K790335HYCEL MFebruary 27, 1979
K782116KETOSTEROID TEST, HYCEL-17January 26, 1979
K782176HYCEL LDH-INT TESTJanuary 26, 1979
K782101HYCEL COUNTER 222January 3, 1979
K782100HYCEL COUNTER 333January 3, 1979
K782102HYCEL COUNTER 211January 3, 1979
K781004HMA URIC ACID TESTJuly 27, 1978
K780946ROYCO MODEL 970 HEMATOLOGY DATA ANALYZERJuly 27, 1978
K780464LELECTIVE KINETIC SYSTEM-60May 3, 1978
K780262DIRECT UREA NITROGEN TESTApril 5, 1978
K77242617-HYDROXY TESTJanuary 30, 1978
K771259ALBUMIN TEST, HMA ALBUMIN TESTAugust 22, 1977
K771353PLATELET COUNTER & HEMATOCRIT ACCES.August 10, 1977
K771343LDH-INT TESTAugust 10, 1977
K771154CPK-INT TESTJuly 21, 1977
K771107COUNTER 700 & HC-700 HEMO 0 REF.July 11, 1977
K770803HEMOTOLOGY PRODU&TS (5 IN ALL)July 5, 1977
K770643CREATININE TEST, SUPER SEVENTEENJune 24, 1977
K770748TEST, FERROZINE IRON & IRON BINDINGJune 1, 1977