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510(k) K862141

HISTOLOGY PARAFFIN by Erie Scientific Co. — Product Code KEO

K862141 is an FDA 510(k) premarket notification submitted by Erie Scientific Co. for the device "HISTOLOGY PARAFFIN". The FDA issued a decision of Substantially Equivalent on June 13, 1986. The device falls under product code KEO (Formulations, Paraffin, All), a Class I device regulated under 21 CFR 864.4010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1986
Date Received
June 4, 1986
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

Other clearances for product code KEO

  • K893772 — TISSUE EMBEDDING MEDIUM (June 22, 1989)
  • K862223 — MICRO THIN* PARAFFIN (June 17, 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)
  • K803241 — HISTOLOGICAL EMBEDDING MEDIA (January 28, 1981)
  • K760602 — SORVALL EMBEDDING MEDIUM (September 21, 1976)

FDA data resources