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510(k) K914696

MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 by Medix Biotech, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1991
Date Received
October 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Medix Biotech, Inc.

  • K952873 — MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) (September 8, 1995)
  • K952319 — CONTRAST & RAPID HCG URINE/SERUM TST (June 20, 1995)
  • K932482 — MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 (July 18, 1994)
  • 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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