AIA-PACK T-U— 510(k) K913663

Substantially Equivalent

Tosoh Corp.

FDA 510(k) clearance K913663 for AIA-PACK T-U, Substantially Equivalent on 1991-09-30. Applicant: Tosoh Corp.. Device class: 2.

Clearance details

Applicant: Tosoh Corp.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1991-08-16
Decision date: 1991-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHQ

K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS1998-06-10
K980088 — T-UPTAKE MICROPLATE EIA1998-02-04
K970539 — CHIRON DIAGNOSTICS ACS:180TU P1997-03-24
K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)1996-11-27
K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

More clearances from Tosoh Corp.

K023239 — AIA-PACK CA 19-92002-12-23
K023240 — ST AIA-PACK CA 19-92002-12-23
K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM1992-07-21
K913298 — AIA-PACK CK-MB1991-09-27
K913493 — AIA-PACK FT41991-09-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.