Home / 510(k) Clearances / K833071

510(k) K833071

TECHNICON PARACUT by Technicon Instruments Corp. — Product Code KEO

K833071 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON PARACUT". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code KEO (Formulations, Paraffin, All), a Class I device regulated under 21 CFR 864.4010. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
September 8, 1983
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 Technicon Instruments Corp.

  • K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST) (November 27, 1991)
  • K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL (November 27, 1991)
  • K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) (November 22, 1991)
  • K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES (September 25, 1991)
  • K912413 — CHEM-LINK DATA BASE MANAGER (July 1, 1991)
  • K903305 — TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD (September 27, 1990)
  • K903825 — DRUG OF ABUSE ANALYSIS SYSTEM (September 27, 1990)
  • K903824 — DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY (September 27, 1990)
  • K903306 — TECHNICON CHEM I SYSTEM MAGNESIUM METHOD (August 29, 1990)
  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)

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)
  • 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