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510(k) K943493

DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER by Hamilton Co. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1995
Date Received
July 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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  • K832204 — MICROLAB P (August 24, 1983)
  • K832200 — PRP-1 REVERSED PHASE COLUMNS FOR HPLC (August 16, 1983)
  • K832201 — CHROM-PREP (August 16, 1983)
  • K832199 — HC40/HC75 CATION EXCHANGE RESIN (August 16, 1983)

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