Thrombo Screen Quantitative Heparin Assa

FDA 510(k) K770722 · Bay Area Hema. Onco. Clinic. & Res. L

Substantially Equivalent

510(k) numberK770722

Submission

Device name
Thrombo Screen Quantitative Heparin Assa
Applicant
Bay Area Hema. Onco. Clinic. & Res. L
Mchenry, IL, US
Received
April 19, 1977
Decision date
July 11, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JBR – Test, Heparin Neutralization
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7525
Specialty
Hematology

Other 510(k)s with product code JBR

510(k)DeviceApplicantDecision
K925452Dade HepzymeJBR · Traditional Baxter Diagnostics, Inc.01/11/1993SE
K874373PT Pro-ClotJBR · Traditional Probe-Tek, Inc.01/05/1988SE

More from Probe-Tek, Inc.

510(k)DeviceDecision
K771678Thrombo-Screen Platelet AdhesionJBZ · Traditional 11/22/1977SE
K770394Thrombo-Screen AT-111 KitJBQ · Traditional 03/30/1977SE
K770395Thrombo-Cetin (Ristocetin)JOZ · Traditional 03/21/1977SE

Questions and answers

When was Thrombo Screen Quantitative Heparin Assa cleared by the FDA?

Thrombo Screen Quantitative Heparin Assa (K770722) received a 510(k) decision of Substantially Equivalent on July 11, 1977, 83 days after the submission was received.

What is the product code of K770722?

The FDA product code is JBR – Test, Heparin Neutralization, a Class II (moderate risk) device regulated under 21 CFR 864.7525.