OBA(TM) READER— 510(k) K911045

Substantially Equivalent

Adeza Biomedical

FDA 510(k) clearance K911045 for OBA(TM) READER, Substantially Equivalent on 1991-06-24. Applicant: Adeza Biomedical. Device class: 1.

Clearance details

Applicant: Adeza Biomedical
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1991-03-08
Decision date: 1991-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Adeza Biomedical

K911047 — OBA(TM) SERUM HCG ASSAY1991-06-24
K900225 — ROMCHECK SPECIMEN COLLECTION KIT1990-02-02

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