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510(k) K940003

VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT by Buckman Co., Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1995
Date Received
January 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

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  • K945756 — IMAGN(TM) 2000 SYSTEM (December 19, 1995)
  • K951117 — LIHTAN 532 LASER (October 18, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)
  • K934429 — ANTERIOR SPINE SYSTEM (October 20, 1994)

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