T-UPTAKE MICROPLATE EIA— 510(k) K980088

Substantially Equivalent

Monobind

FDA 510(k) clearance K980088 for T-UPTAKE MICROPLATE EIA, Substantially Equivalent on 1998-02-04. Applicant: Monobind. Device class: 2.

Clearance details

Applicant: Monobind
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1998-01-09
Decision date: 1998-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHQ

K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS1998-06-10
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
K954807 — CEDIA T UPTAKE ASSAY1995-12-21

More clearances from Monobind

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