Last synced on 14 November 2025 at 11:06 pm

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187

Page Type
Cleared 510(K)
510(k) Number
K894366
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/31/1989
Days to Decision
48 days

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187

Page Type
Cleared 510(K)
510(k) Number
K894366
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/31/1989
Days to Decision
48 days