ALBP— 510(k) K981457

Substantially Equivalent

Abbott Mfg., Inc.

FDA 510(k) clearance K981457 for ALBP, Substantially Equivalent on 1998-05-27. Applicant: Abbott Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Abbott Mfg., Inc.
Product code: Code CJW
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 1998-04-23
Decision date: 1998-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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