BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007— 510(k) K991432
Substantially EquivalentBiocheck, Inc.
FDA 510(k) clearance K991432 for BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007, Substantially Equivalent on 1999-06-02. Applicant: Biocheck, Inc.. Device class: 2.
Clearance details
- Applicant
- Biocheck, Inc.
- Product code
- Code KLI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
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Recalls naming K991432
K-number listed on FDA's recall record- Z-0310-2022 — Total Thyroxine (T4) ELISA; REF EIA-1781
- Z-0214-2022 — T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991432.
Data sourced from openFDA. This site is unofficial and independent of the FDA.