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510(k) K980314

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

K980314 is an FDA 510(k) premarket notification submitted by Biopool Intl., Inc. for the device "FETAL D TECTION KIT". The FDA issued a decision of Substantially Equivalent on April 8, 1998. The device falls under product code LIM (Test, Screening, For D Positive Fetal Rbc'S), a Class II device regulated under 21 CFR 864.7455. Biopool Intl., Inc. has at least 3 other 510(k) clearances on record.

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.

  • K002642 — MINIQUANT D-DIMER, MODEL 1447 (February 5, 2001)
  • 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)

FDA data resources