VENTREX COATED TUBE T3 UPTAKE— 510(k) K891068

Name: FDA 510(k) clearance K891068
Creator: U.S. Food and Drug Administration
Published: 1989-04-10

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K891068 for VENTREX COATED TUBE T3 UPTAKE, Substantially Equivalent on 1989-04-10. Applicant: Ventrex Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1989-03-01
Decision date: 1989-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

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Recent devices under product code KHQ

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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 Ventrex Laboratories, Inc.

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K914554 — SPECIFIC IGE EIA-TURBO ASSAY1992-03-13
K913833 — VENTREX ALLERGEN DISC1992-02-21
K913434 — VENTREX COATED TUBE INTACT PTH1991-10-25
K905612 — VENTREX COATED TUBE IGE RADIOIMMUNOASSAY1991-02-21
K905636 — VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY1991-02-07

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