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510(k) K801491

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

K801491 is an FDA 510(k) premarket notification submitted by Microanalytic Research, Inc. for the device "MRI HCG-BETA RIA KIT CAT. #MR-10100". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Microanalytic Research, Inc. has at least 7 other 510(k) clearances on record.

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)

Other clearances for product code JHI

  • K241919 — Innovita HCG Pregnancy Rapid Combo Test (August 2, 2024)
  • K203272 — Alltest Pregnancy Rapid Combo Test Cassette (January 31, 2022)
  • K172322 — Atellica IM Total hCG (ThCG) (March 29, 2018)
  • K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Resu (December 22, 2017)
  • K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregn (February 24, 2016)
  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
  • K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST (January 9, 2014)
  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
  • K123844 — CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND H (May 30, 2013)
  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)

FDA data resources