VARELISA ANA (4) PROFILE— 510(k) K963291

Substantially Equivalent

Elias U.S.A., Inc.

FDA 510(k) clearance K963291 for VARELISA ANA (4) PROFILE, Substantially Equivalent on 1996-09-30. Applicant: Elias U.S.A., Inc.. Device class: 2.

Clearance details

Applicant: Elias U.S.A., Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1996-08-21
Decision date: 1996-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osceola, WI, US

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More clearances from Elias U.S.A., Inc.

K964385 — ELIAS ANA-HEP-21997-03-06
K953873 — VARELISA HELICOBACTER PYLORI ANTIBODIES1996-08-30
K953586 — VARELISA PR3-ANCA1996-01-26
K953587 — VARELISA MPO-ANCA1996-01-26
K951187 — VARELISA CARDIOLIPIN ABS SCREEN1995-10-02

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