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510(k) K803241

HISTOLOGICAL EMBEDDING MEDIA by Miles Laboratories, Inc. — Product Code KEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1981
Date Received
December 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formulations, Paraffin, All
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

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  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (October 28, 1987)
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  • K872634 — CUTTER PUREFLO PLUS IV FILTER (August 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 1987)

Other clearances for product code KEO

  • K893772 — TISSUE EMBEDDING MEDIUM (June 22, 1989)
  • K862223 — MICRO THIN* PARAFFIN (June 17, 1986)
  • K862141 — HISTOLOGY PARAFFIN (June 13, 1986)
  • K861270 — BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (April 11, 1986)
  • K842053 — PARAPLAST EXTRA TISSUE EMBEDDING MED. (June 26, 1984)
  • K833071 — TECHNICON PARACUT (October 14, 1983)
  • K831580 — PARAFFIN INFILTRATION MEDIUM (June 17, 1983)
  • K812191 — VASPAR SEALENT (August 31, 1981)
  • K810568 — PARAFFIN EMBEDDING MEDIUM (March 17, 1981)
  • K760602 — SORVALL EMBEDDING MEDIUM (September 21, 1976)