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510(k) K950415

FLUOROSCAN NEONATAL by Isolab, Inc. — Product Code KHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1995
Date Received
January 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
Submission Type

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  • K934013 — RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (April 26, 1994)
  • K923153 — HEMOCARD, HEMOGLOBIN C ASSAY (January 27, 1994)
  • K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE (May 11, 1993)

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  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)
  • K920888 — MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (March 19, 1992)