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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 021 Date of Recognition 03/18/2009 
FR Recognition Number 7-164
Standard
CLSI GP28-A (Replaces GP28-P)
Microwave Device Use in the Histology Laboratory; Approved Guideline
Scope/Abstract
This document provides recommendations for reproducing the performance of microwave-accelerated procedures to prepare biological specimens in the histology laboratory.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§864.3010 Apparatus, Melting Point, Paraffin Class 1 IDT
§864.3010 Lamps, Slide Warming Class 1 IEH
§864.3010 Ovens, Paraffin Class 1 IDR
§864.3010 Table, Slide Warming Class 1 IEG
Relevant FDA Guidance and/or Supportive Publications
CLSI MM-4 Quality Assurance for Immunocytochemistry; Approved Guideline.
FDA Technical Contacts
 Janaki Veeraraghavan
  FDA/OMPT/CDRH/OIR/DMGP/MGB/
  240-402-6634
  Janaki.Veeraraghavan@fda.hhs.gov
 Shyam Kalavar
  FDA/OMPT/CDRH/OIR/DMGP/MPCB/
  301-796-6807
  shyam.kalavar@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
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