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510(k) K871286

GRAM IODINE by Remel Co. — Product Code HYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1987
Date Received
March 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iodine, Grams
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

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  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K031565 — XPECT INFLUENZA A/B (July 17, 2003)

Other clearances for product code HYI

  • K842733 — GRAM IODINE (August 10, 1984)
  • K821977 — GRAMSTAIN SET (July 22, 1982)
  • K811722 — PARA-PAK (July 15, 1981)
  • K791711 — IMPROVED GRAM STAIN REAGENTS (October 17, 1979)
  • K781584 — GRAM STAIN KIT (October 10, 1978)