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510(k) K770722

THROMBO SCREEN QUANTITATIVE HEPARIN ASSA by Bay Area Hema. Onco. Clinic. & Res. L — Product Code JBR

K770722 is an FDA 510(k) premarket notification submitted by Bay Area Hema. Onco. Clinic. & Res. L for the device "THROMBO SCREEN QUANTITATIVE HEPARIN ASSA". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code JBR (Test, Heparin Neutralization), a Class II device regulated under 21 CFR 864.7525. Bay Area Hema. Onco. Clinic. & Res. L has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1977
Date Received
April 19, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Heparin Neutralization
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

Other clearances by Bay Area Hema. Onco. Clinic. & Res. L

  • K771678 — THROMBO-SCREEN PLATELET ADHESION (November 22, 1977)
  • K770394 — THROMBO-SCREEN AT-111 KIT (March 30, 1977)
  • K770395 — THROMBO-CETIN (RISTOCETIN) (March 21, 1977)

Other clearances for product code JBR

  • K925452 — DADE HEPZYME (January 11, 1993)
  • K874373 — PT PRO-CLOT (January 5, 1988)

FDA data resources