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510(k) K897144

THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT by Medix Biotech, Inc. — Product Code KLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1990
Date Received
December 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

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  • K932758 — MEDIX BIOTECH BESTEST HCG-URINE TEST KIT (September 28, 1993)
  • K925436 — MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT (December 28, 1992)
  • K924259 — MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 (November 25, 1992)
  • K922047 — IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 (August 5, 1992)
  • K921700 — TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 (June 29, 1992)
  • K920712 — MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT (March 27, 1992)
  • K920345 — PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) (March 18, 1992)

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