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510(k) K920001

HEMOLAB SILIMAT REAGENT by Biomerieux Vitek, Inc. — Product Code GFI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1992
Date Received
January 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Osteotome, Manual
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
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Other clearances for product code GFI

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  • K932534 — ISI FENESTRATED DISSECTING AND GRASPING FORCEPS (August 19, 1993)
  • K891887 — OSTEOTOMES, VARIOUS TYPES (April 12, 1989)
  • K852541 — STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS (July 11, 1985)
  • K842823 — CHERMEL OSTEOTOMES (August 2, 1984)