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510(k) K973074

2487 DUAL WAVELENGTH ABSORBANCE DETECTOR by Waters Corporation — Product Code KZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1997
Date Received
August 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography (Liquid, Gel), Clinical Use
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type

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  • K851945 — VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM (May 24, 1985)
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  • K840977 — LIQUID CHROMATOGRAPHIC DETECTOR LC-95 (April 19, 1984)
  • K832201 — CHROM-PREP (August 16, 1983)
  • K802725 — VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS (December 11, 1980)