HAPTOGLOBIN— 510(k) K873866

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K873866 for HAPTOGLOBIN, Substantially Equivalent on 1987-10-20. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code DAD
Device class: Class 2
Regulation: 21 CFR 866.5460
Advisory panel: Immunology
Date received: 1987-08-24
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford Mk41 Oqg, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code DAD

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K963286 — IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT1996-10-07
K952593 — N/T PROTEIN CONTROL SY/L, M AND H1995-07-17

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