LEECO PREVIEW(R) EBV (EIA)— 510(k) K895765

Name: FDA 510(k) clearance K895765
Creator: U.S. Food and Drug Administration
Published: 1989-10-31

Substantially Equivalent

Leeco Diagnostics, Inc.

FDA 510(k) clearance K895765 for LEECO PREVIEW(R) EBV (EIA), Substantially Equivalent on 1989-10-31. Applicant: Leeco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Leeco Diagnostics, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1989-09-26
Decision date: 1989-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southfield, MI, US

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More clearances from Leeco Diagnostics, Inc.

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K894122 — LEECO VIS-DISK STREP-A (EIA)1989-08-15
K891095 — VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M1989-06-16
K891096 — VIS-DISK HCG (EIA) JPL-041M1989-06-16
K883269 — PRL-QUANT1988-09-13
K880577 — CONCEP-7-BHCG1988-03-15

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