510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980314Substantially Equivalent

Fetal D Tection Kit

Biopool Intl., Inc., West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980314 is the FDA 510(k) clearance record for FETAL D TECTION KIT, a class II device, cleared for Biopool Intl., Inc. on under FDA product code LIM (Test, Screening, For D Positive Fetal Rbc'S). FDA records list 4 510(k) clearances for Biopool Intl., Inc., from to . As of , FDA records show no recalls naming K980314.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LIM Test, Screening, For D Positive Fetal Rbc'S
Regulation
21 CFR 864.7455
Device class
Class II
Review panel
Hematology
Applicant
Biopool Intl., Inc. 1230 Wilson Dr., West Chester PA
510(k) summary
Statement
Third party review
No

Clearances, product code LIM

Trailing 12 months

FDA records hold no clearances under product code LIM in the trailing twelve months.

FDA records show no clearances under product code LIM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260