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510(k) K914809

MP MINI PHOTOMETER by Artel, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1992
Date Received
October 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Artel, Inc.

  • K933836 — HBM HEMOGLOBINOMETER (March 31, 1994)
  • K920914 — MP/S SINGLE WAVELENGTH MINI PHOTOMETER (March 23, 1992)
  • K864542 — ARTEL DIFFERENTIAL PHOTOMETER (February 6, 1987)

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