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510(k) K901674

AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM by Tosoh Corp. — Product Code KHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1990
Date Received
April 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
Submission Type

Other clearances by Tosoh Corp.

  • K023239 — AIA-PACK CA 19-9 (December 23, 2002)
  • K023240 — ST AIA-PACK CA 19-9 (December 23, 2002)
  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)
  • K913663 — AIA-PACK T-U (September 30, 1991)
  • K913298 — AIA-PACK CK-MB (September 27, 1991)
  • K913493 — AIA-PACK FT4 (September 10, 1991)
  • K903628 — AIA-PACK IRI (September 7, 1990)
  • K901965 — MPR-4A - MICRO-PLATE READER (May 10, 1990)
  • K897001 — TOSOH AIA-PACK T3 (March 9, 1990)
  • K896982 — AIA-PACK T4 (March 9, 1990)

Other clearances for product code KHO

  • K112161 — AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, (January 20, 2012)
  • K973547 — TRIAGE STATMETER (January 13, 1998)
  • K971103 — AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (June 27, 1997)
  • K962919 — VITROS IMMUNODIAGNOSTIC SYSTEM (October 18, 1996)
  • K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (November 22, 1995)
  • K950415 — FLUOROSCAN NEONATAL (September 5, 1995)
  • K935047 — AUTO DELFIA (May 23, 1994)
  • K930689 — AUTOBEAD THYROID UPTAKE (November 10, 1993)
  • K926131 — OPUS MAGNUM ANALYZER (June 7, 1993)
  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)