SRI TSH IMMUNENZYMETRIC ASSAY— 510(k) K910837

Name: FDA 510(k) clearance K910837
Creator: U.S. Food and Drug Administration
Published: 1991-05-24

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

FDA 510(k) clearance K910837 for SRI TSH IMMUNENZYMETRIC ASSAY, Substantially Equivalent on 1991-05-24. Applicant: Serono-Baker Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code JLW
Device class: Class 2
Regulation: 21 CFR 862.1690
Advisory panel: Clinical Chemistry
Date received: 1991-02-27
Decision date: 1991-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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K915602 — SRI DIGOXIN ENZYME IMMUNOASSAY1992-01-17
K912937 — SR1 FREE T4 ENZYME IMMUNOASSAY1991-11-19

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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