ZETA-SERA D— 510(k) K812329

Substantially Equivalent

Amf Biological and Diagnostics Co.

FDA 510(k) clearance K812329 for ZETA-SERA D, Substantially Equivalent on 1981-09-01. Applicant: Amf Biological and Diagnostics Co.. Device class: 1.

Clearance details

Applicant: Amf Biological and Diagnostics Co.
Product code: Code KIS
Device class: Class 1
Regulation: 21 CFR 864.2800
Advisory panel: Hematology
Date received: 1981-08-18
Decision date: 1981-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K870580 — MLC NORMAL SERUM1987-04-08

More clearances from Amf Biological and Diagnostics Co.

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K821553 — ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT1982-06-25
K821554 — ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT1982-06-25

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