CALTAG FETAL HEMOGLOBIN TEST— 510(k) K990641

Name: FDA 510(k) clearance K990641
Creator: U.S. Food and Drug Administration
Published: 1999-09-17

Substantially Equivalent

Caltag Laboratories, Inc.

FDA 510(k) clearance K990641 for CALTAG FETAL HEMOGLOBIN TEST, Substantially Equivalent on 1999-09-17. Applicant: Caltag Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Caltag Laboratories, Inc.
Product code: Code GHQ
Device class: Class 2
Regulation: 21 CFR 864.7455
Advisory panel: Hematology
Date received: 1999-02-26
Decision date: 1999-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dowingtown, PA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K990641

K-number listed on FDA's recall record

Z-1388-2018 — Human Fetal Hemoglobin (HBF-1) FITC ConjugateClass II·Terminated·Life Technologies Corporation·20180207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990641.

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