T-UPTAKE EIA TEST— 510(k) K951586

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K951586 for T-UPTAKE EIA TEST, Substantially Equivalent on 1995-05-15. Applicant: Diagnostic Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1995-04-06
Decision date: 1995-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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 Diagnostic Reagents, Inc.

K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY1998-11-18
K983812 — NAPA EIA ASSAY1998-11-16
K983323 — DIGOXIN IMMUNOASSAY1998-11-12
K983280 — VANCOMYCIN EIA ASSAY1998-11-06
K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS1998-11-05

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