Fetal D Tection Kit

FDA 510(k) K980314 · Biopool Intl., Inc.

Substantially Equivalent

510(k) numberK980314

Submission

Device name
Fetal D Tection Kit
Applicant
Biopool Intl., Inc.
West Chester, PA, US
Received
January 27, 1998
Decision date
April 8, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LIM – Test, Screening, For D Positive Fetal Rbc'S
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7455
Specialty
Hematology

Other 510(k)s with product code LIM

510(k)DeviceApplicantDecision
K820647Gamma Fetal Bleed Screening TestLIM · Traditional Gamma Biologicals, Inc.05/12/1982SE

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K981752I-Stat Coagulation Control SetGGN · Traditional 06/15/1998SE

Questions and answers

When was Fetal D Tection Kit cleared by the FDA?

Fetal D Tection Kit (K980314) received a 510(k) decision of Substantially Equivalent on April 8, 1998, 71 days after the submission was received.

What is the product code of K980314?

The FDA product code is LIM – Test, Screening, For D Positive Fetal Rbc'S, a Class II (moderate risk) device regulated under 21 CFR 864.7455.