SERO/TEX MONO TEST— 510(k) K821386

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K821386 for SERO/TEX MONO TEST, Substantially Equivalent on 1982-07-02. Applicant: Texas Immunology, Inc.. Device class: 2.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1982-05-10
Decision date: 1982-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Texas Immunology, Inc.

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K973208 — FIRST SIGN1997-10-20
K972094 — TARGET CARDIAC TROPONIN I TEST1997-07-23
K963680 — TARGET MYOGLOBIN TEST1997-02-06

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