Biosure Specimen Collection Container

FDA 510(k) K873593 · Biosure, Inc.

Substantially Equivalent

510(k) numberK873593

Submission

Device name
Biosure Specimen Collection Container
Applicant
Biosure, Inc.
San Jose, CA, US
Received
September 4, 1987
Decision date
November 25, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KDT – Container, Specimen Mailer And Storage, Sterile
Device class
Class I (low risk)
Regulation
21 CFR 864.3250
Specialty
Pathology

Other 510(k)s with product code KDT

510(k)DeviceApplicantDecision
K862665Novacyte-UKDT · Traditional Xsirius Medical, Inc.09/04/1986SE
K834579Biospal 2400SKDT · Traditional Hospal Medical Corp.02/04/1984SE
K834412Preserv Pva Fixative 15ML-FORMALIN PKKDT · Traditional Preventive Diagnostics Corp.01/13/1984SE
K833660Preserv Pva Fixative -Malin PackKDT · Traditional Preventive Diagnostics Corp.11/28/1983SE
K823773Provial II #006-010-0201KDT · Traditional Dynatech Corp.01/21/1983SE
K822870Stool-Collection/Preservation KitKDT · Traditional American Scientific Products11/01/1982SE
K821621PregnopostKDT · Traditional M.M. Wolfred, Ph.D.07/21/1982SE
K820246Prefilled Specimen ContainerKDT · Traditional Sage Products, Inc.02/18/1982SE
K811793Fix-Right 90ML & 180 ML Prefilled ContKDT · Traditional Richard-Allan Medical Ind., Inc.07/31/1981SE
K800946Urinary Catheter Sampling KitKDT · Traditional Sage Products, Inc.06/20/1980SE

Questions and answers

When was Biosure Specimen Collection Container cleared by the FDA?

Biosure Specimen Collection Container (K873593) received a 510(k) decision of Substantially Equivalent on November 25, 1987, 82 days after the submission was received.

What is the product code of K873593?

The FDA product code is KDT – Container, Specimen Mailer And Storage, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.