TANDEM - HGH KIT— 510(k) K821366

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K821366 for TANDEM - HGH KIT, Substantially Equivalent on 1982-06-10. Applicant: Hybritech, Inc.. Device class: 1.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1982-05-10
Decision date: 1982-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hybritech, Inc.

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K930810 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY1994-01-11
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Data sourced from openFDA. This site is unofficial and independent of the FDA.