ELISA CMV IGM— 510(k) K914789

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K914789 for ELISA CMV IGM, Substantially Equivalent on 1992-03-04. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code LKQ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1991-10-23
Decision date: 1992-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

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K895943 — NORMAL AND ABNORMAL CONTROL SERA1989-12-27
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K895847 — CREATININE 340 (ENZYMATIC)1989-10-30

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