EASE-A-CULT— 510(k) K002756

Substantially Equivalent

Diagnostica, Inc.

FDA 510(k) clearance K002756 for EASE-A-CULT, Substantially Equivalent on 2001-02-23. Applicant: Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostica, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2000-09-05
Decision date: 2001-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Diagnostica, Inc.

K823348 — H. INFLUENZA B ANTISERA FOR CIE1982-12-28
K812434 — DIAGNOSTIC KITS & KIT COMPONENTS1981-09-23
K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT1980-03-12
K791281 — ANTI-HUMAN IGG SERUM1979-11-27
K791283 — ANTI-HUMAN LAMBDA SERUM1979-11-27

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