FDP COLLECTION TUBES— 510(k) K896033

Name: FDA 510(k) clearance K896033
Creator: U.S. Food and Drug Administration
Published: 1989-10-27

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K896033 for FDP COLLECTION TUBES, Substantially Equivalent on 1989-10-27. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code JCO
Device class: Class 2
Regulation: 21 CFR 864.8100
Advisory panel: Hematology
Date received: 1989-10-16
Decision date: 1989-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCO

view all

K955115 — VENOM TIEM REAGENT1996-04-03
K932787 — BATROXOBIN REAGENT1993-11-29
K852519 — DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE1985-08-12
K843207 — REPTILASE -PC1984-10-23
K840210 — REPTILASE-R HA351984-04-23

More clearances from Medical Diagnostic Technologies, Inc.

view all

K062229 — CTC WORKSTATION, MODEL 22002006-09-11
K972209 — SPECTROLYSE HEPARIN (ANTI-IIA)1997-08-12
K963106 — CHROMOLIZE PAI-1 KIT1996-11-18
K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA)1996-08-14
K962489 — CHROMOLIZE TPA ASSAY KIT1996-07-31

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