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510(k) K893562

A.QC HCT LEVEL 1 AND 2 by Johnson & Johnson Professionals, Inc. — Product Code GLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1989
Date Received
May 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hematocrit
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

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  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)

Other clearances for product code GLK

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  • K020618 — AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL (May 14, 2002)
  • K964452 — HEMATACHEK (February 20, 1997)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (July 26, 1996)
  • K924926 — MSI-HCT (January 7, 1993)