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510(k) K980314

FETAL D TECTION KIT by Biopool Intl., Inc. — Product Code LIM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1998
Date Received
January 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Screening, For D Positive Fetal Rbc'S
Device Class
Class II
Regulation Number
864.7455
Review Panel
HE
Submission Type

Other clearances by Biopool Intl., Inc.

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  • K983898 — BIOCLOT APC SENSITIVITY (January 6, 1999)
  • K981752 — I-STAT COAGULATION CONTROL SET (June 15, 1998)

Other clearances for product code LIM

  • K820647 — GAMMA FETAL BLEED SCREENING TEST (May 12, 1982)