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510(k) K780455

QUANTITATIVE DETERMINATION OF PORPHYRINS by Whale Scientific, Inc. — Product Code JKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
March 20, 1978
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

Other clearances by Whale Scientific, Inc.

  • K855214 — CAT-3 CATECHOLAMINE ASSAY KIT (March 14, 1986)
  • K841506 — META-3 (April 11, 1984)

Other clearances for product code JKJ

  • K893038 — PROTOFLUOR Z (November 17, 1989)
  • K871499 — PROTOFLUOR Z (August 25, 1987)