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510(k) K913663

AIA-PACK T-U by Tosoh Corp. — Product Code KHQ

K913663 is an FDA 510(k) premarket notification submitted by Tosoh Corp. for the device "AIA-PACK T-U". The FDA issued a decision of Substantially Equivalent on September 30, 1991. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Tosoh Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1991
Date Received
August 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Triiodothyronine Uptake
Device Class
Class II
Regulation Number
862.1715
Review Panel
CH
Submission Type

Other clearances by Tosoh Corp.

  • K023240 — ST AIA-PACK CA 19-9 (December 23, 2002)
  • K023239 — AIA-PACK CA 19-9 (December 23, 2002)
  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)
  • 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)
  • K901674 — AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM (May 2, 1990)
  • K896982 — AIA-PACK T4 (March 9, 1990)
  • K897001 — TOSOH AIA-PACK T3 (March 9, 1990)

Other clearances for product code KHQ

  • K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS (June 10, 1998)
  • K980088 — T-UPTAKE MICROPLATE EIA (February 4, 1998)
  • K970539 — CHIRON DIAGNOSTICS ACS:180TU P (March 24, 1997)
  • K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAK (November 27, 1996)
  • K961488 — ELECSYS T-UPTAKE ASSAY (June 12, 1996)
  • K954807 — CEDIA T UPTAKE ASSAY (December 21, 1995)
  • K951586 — T-UPTAKE EIA TEST (May 15, 1995)
  • K933414 — STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (November 22, 1994)
  • K934312 — AXSYM(TM) T-UPTAKE (June 21, 1994)
  • K935816 — VIDAS T UPTAKE (March 22, 1994)

FDA data resources