Thrombo-Screen Platelet Adhesion

FDA 510(k) K771678 · Bay Area Hema. Onco. Clinic. & Res. L

Substantially Equivalent

510(k) numberK771678

Submission

Device name
Thrombo-Screen Platelet Adhesion
Applicant
Bay Area Hema. Onco. Clinic. & Res. L
Mchenry, IL, US
Received
September 2, 1977
Decision date
November 22, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JBZ – Study, Platelet Adhesive
Device class
Class II (moderate risk)
Regulation
21 CFR 864.6650
Specialty
Hematology

Other 510(k)s with product code JBZ

510(k)DeviceApplicantDecision
K800037Platelet Retention (Adhesion) ColumnsJBZ · Traditional Hemometrix02/05/1980SE
K771523Latelet Retention ColumnJBZ · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic11/22/1977SE

More from Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k)DeviceDecision
K770722Thrombo Screen Quantitative Heparin AssaJBR · Traditional 07/11/1977SE
K770394Thrombo-Screen AT-111 KitJBQ · Traditional 03/30/1977SE
K770395Thrombo-Cetin (Ristocetin)JOZ · Traditional 03/21/1977SE

Questions and answers

When was Thrombo-Screen Platelet Adhesion cleared by the FDA?

Thrombo-Screen Platelet Adhesion (K771678) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 81 days after the submission was received.

What is the product code of K771678?

The FDA product code is JBZ – Study, Platelet Adhesive, a Class II (moderate risk) device regulated under 21 CFR 864.6650.