PHOTON IMMUNOASSAY ANALYZER— 510(k) K832364

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K832364 for PHOTON IMMUNOASSAY ANALYZER, Substantially Equivalent on 1983-08-26. Applicant: Hybritech, Inc.. Device class: 1.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1983-07-18
Decision date: 1983-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.