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510(k) K893038

PROTOFLUOR Z by Helena Laboratories — Product Code JKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1989
Date Received
April 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Measurement, Porphyrins
Device Class
Class I
Regulation Number
862.1595
Review Panel
CH
Submission Type

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Other clearances for product code JKJ

  • K871499 — PROTOFLUOR Z (August 25, 1987)
  • K780455 — QUANTITATIVE DETERMINATION OF PORPHYRINS (July 27, 1978)