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Device Classification
/ LIM
LIM — Test, Screening, For D Positive Fetal Rbc'S
Class II
FDA Device Classification
Classification Details
Product Code
LIM
Device Class
Class II
Regulation Number
864.7455
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K980314
biopool intl
FETAL D TECTION KIT
April 8, 1998
K820647
gamma biologicals
GAMMA FETAL BLEED SCREENING TEST
May 12, 1982