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510(k) K993536

BIO-RAD CODA NEONATAL GALT ASSAY by Bio-Rad — Product Code KQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1999
Date Received
October 19, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Device Class
Class II
Regulation Number
862.1315
Review Panel
CH
Submission Type

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Other clearances for product code KQP

  • K102643 — SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT (July 15, 2011)
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  • K990827 — MICROPLATE NEONATAL GALT ASSAY (April 9, 1999)
  • K970277 — URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (December 11, 1997)
  • K894011 — TOTAL GALACTOSE (January 11, 1990)