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510(k) K801491

MRI HCG-BETA RIA KIT CAT. #MR-10100 by Microanalytic Research, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1980
Date Received
June 26, 1980
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 Microanalytic Research, Inc.

  • K861097 — TRYPSIN RIA KIT (May 29, 1986)
  • K820741 — MR1 LUTROPIN RIA KIT (April 14, 1982)
  • K820740 — MR1 FOLLITROPIN RIA KIT (April 6, 1982)
  • K813516 — MRI TOBRAMYCIN RIA KIT (December 29, 1981)
  • K812394 — MRI GENTAMICIN RIA KIT (September 8, 1981)
  • K810949 — MRI PROLACTIN RIA KIT (July 10, 1981)
  • K802754 — IMMUNOREACTIVE ESTRIOL RIA KIT (January 21, 1981)

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