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510(k) K893772

TISSUE EMBEDDING MEDIUM by Stephens Scientific — Product Code KEO

K893772 is an FDA 510(k) premarket notification submitted by Stephens Scientific for the device "TISSUE EMBEDDING MEDIUM". The FDA issued a decision of Substantially Equivalent on June 22, 1989. The device falls under product code KEO (Formulations, Paraffin, All), a Class I device regulated under 21 CFR 864.4010. Stephens Scientific has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
May 22, 1989
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 by Stephens Scientific

  • K881359 — DECALCIFYING SOLUTION II (April 19, 1988)
  • K872625 — DECALCIFYING SOLUTION (August 6, 1987)
  • K832011 — AMERI CLEAR (August 12, 1983)

Other clearances for product code KEO

  • 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)
  • K803241 — HISTOLOGICAL EMBEDDING MEDIA (January 28, 1981)
  • K760602 — SORVALL EMBEDDING MEDIUM (September 21, 1976)

FDA data resources