MDI SS-A TEST— 510(k) K993636

Substantially Equivalent

Micro Detect, Inc.

FDA 510(k) clearance K993636 for MDI SS-A TEST, Substantially Equivalent on 2000-01-10. Applicant: Micro Detect, Inc.. Device class: 2.

Clearance details

Applicant: Micro Detect, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1999-10-27
Decision date: 2000-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Micro Detect, Inc.

K003794 — ELISA TEST, SEROLOGY2001-03-30
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Data sourced from openFDA. This site is unofficial and independent of the FDA.