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510(k) K831364

TESTCORP RA by Myo-Tronics Research, Inc. — Product Code DCN

K831364 is an FDA 510(k) premarket notification submitted by Myo-Tronics Research, Inc. for the device "TESTCORP RA". The FDA issued a decision of Substantially Equivalent on May 27, 1983. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Myo-Tronics Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1983
Date Received
April 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Myo-Tronics Research, Inc.

  • K842224 — BNS 40 (November 19, 1984)
  • K842223 — J4 MYO-MONITOR (November 19, 1984)
  • K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (February 10, 1984)
  • K830034 — MODEL EM-2 BIOELECTRIC PROCESSOR (February 9, 1983)
  • K813533 — ELECTRIC MUSCLE STIMULATOR (March 5, 1982)
  • K810528 — MODEL EM-IR (March 31, 1981)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)

Other clearances for product code DCN

  • K232624 — CardioPhase® hsCRP (November 27, 2023)
  • K221119 — RCRP Flex reagent cartridge (March 17, 2023)
  • K192072 — Tina-quant C-Reactive Protein IV (February 21, 2020)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optil (February 28, 2018)
  • K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (January 12, 2018)
  • K161982 — C-Reactive Protein Kit for use on SPAPLUS (April 5, 2017)
  • K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (August 17, 2012)
  • K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (January 15, 2010)
  • K083444 — C-REACTIVE PROTEIN (LATEX) (March 18, 2009)

FDA data resources