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510(k) K810899

TECHNICON AUTOGROUPER 16-C SYSTEM by Technicon Instruments Corp. — Product Code KSZ

K810899 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON AUTOGROUPER 16-C SYSTEM". The FDA issued a decision of Substantially Equivalent on May 5, 1981. The device falls under product code KSZ (System, Test, Automated Blood Grouping And Antibody), a Class II device regulated under 21 CFR 864.9175. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1981
Date Received
April 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Automated Blood Grouping And Antibody
Device Class
Class II
Regulation Number
864.9175
Review Panel
HE
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)
  • K903825 — DRUG OF ABUSE ANALYSIS SYSTEM (September 27, 1990)
  • K903305 — TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD (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 KSZ

  • K790282 — ELDONCARD (May 4, 1979)
  • K771098 — BLOOD GROUPING SYS., BG-9 (August 4, 1977)
  • K770185 — RH CONTROL DILUENT (March 14, 1977)

FDA data resources