INSTACCULT


definition

Device Classification Name

reagent, occult blood

510(k) Number K002930
Device Name INSTACCULT
Original Applicant
MEDTEK DIAGNOSTICS, LLC.
po box 14125
research triangle park, 
NC 
27709 -4125

Original Contact liane f gosset
Regulation Number 864.6550
Classification Product Code
KHE  
Date Received 09/20/2000
Decision Date 01/22/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No