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510(k) K771678

THROMBO-SCREEN PLATELET ADHESION by Bay Area Hema. Onco. Clinic. & Res. L — Product Code JBZ

K771678 is an FDA 510(k) premarket notification submitted by Bay Area Hema. Onco. Clinic. & Res. L for the device "THROMBO-SCREEN PLATELET ADHESION". The FDA issued a decision of Substantially Equivalent on November 22, 1977. The device falls under product code JBZ (Study, Platelet Adhesive), a Class II device regulated under 21 CFR 864.6650. 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
November 22, 1977
Date Received
September 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Study, Platelet Adhesive
Device Class
Class II
Regulation Number
864.6650
Review Panel
HE
Submission Type

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

  • K770722 — THROMBO SCREEN QUANTITATIVE HEPARIN ASSA (July 11, 1977)
  • K770394 — THROMBO-SCREEN AT-111 KIT (March 30, 1977)
  • K770395 — THROMBO-CETIN (RISTOCETIN) (March 21, 1977)

Other clearances for product code JBZ

  • K800037 — PLATELET RETENTION (ADHESION) COLUMNS (February 5, 1980)
  • K771523 — LATELET RETENTION COLUMN (November 22, 1977)

FDA data resources