ZETA-CORT— 510(k) K821931

Substantially Equivalent

Amf Biological and Diagnostics Co.

FDA 510(k) clearance K821931 for ZETA-CORT, Substantially Equivalent on 1982-07-22. Applicant: Amf Biological and Diagnostics Co.. Device class: 2.

Clearance details

Applicant: Amf Biological and Diagnostics Co.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1982-06-29
Decision date: 1982-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amf Biological and Diagnostics Co.

K852418 — QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)1985-07-15
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K821554 — ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT1982-06-25
K812329 — ZETA-SERA D1981-09-01

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