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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 021 FR Publication Date: 03/18/2009 

Part B: Supplementary Information

Recognition Number 7-164: CLSI GP28-A, microwave device use in the histology laboratory; approved guideline. (InVitro Diagnostics)

Date of Standard: 2005. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
Devices Affected:
Any IVD requiring microwave-accelerated procedures in the Histopathology Laboratory
Processes Affected:
Device Evaluation: 510(k), PMA, IDE, HDE
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
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 Guidance:
CLSI MM-4, Quality Assurance for Immunocytochemistry (Relevant to the antigen retrieval technique)
FDA Technical Contact:
 Kim Collins
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5258
  Silver Spring MD 20993
  301/796-1556
  email: kim.collins@fda.hhs.gov
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