PROGESTERONE— 510(k) K790440

Substantially Equivalent

Serono Laboratories, Inc.

FDA 510(k) clearance K790440 for PROGESTERONE, Substantially Equivalent on 1979-05-03. Applicant: Serono Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Serono Laboratories, Inc.
Product code: Code JLS
Device class: Class 1
Regulation: 21 CFR 862.1620
Advisory panel: Clinical Chemistry
Date received: 1979-03-07
Decision date: 1979-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Serono Laboratories, Inc.

K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT1984-03-02
K810695 — ESTRIOL RADIOIMMUNOASSAY TEST KIT1981-03-31
K810625 — HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-1981-03-27
K792043 — PAP-CHECK RIA KIT1979-10-30
K790679 — ESTRADIOL RIA KIT1979-05-23

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