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510(k) K920504

MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT by Medix Biotech, Inc. — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1992
Date Received
February 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
Review Panel
CH
Submission Type

Other clearances by Medix Biotech, Inc.

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  • 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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