RIA KIT, GLUCOSE— 510(k) K782143

Substantially Equivalent

Serono Laboratories, Inc.

FDA 510(k) clearance K782143 for RIA KIT, GLUCOSE, Substantially Equivalent on 1979-02-22. Applicant: Serono Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Serono Laboratories, Inc.
Product code: Code JME
Device class: Class 1
Regulation: 21 CFR 862.1335
Advisory panel: Clinical Chemistry
Date received: 1978-12-27
Decision date: 1979-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JME

K893975 — DOUBLE ANTIBODY GLUCAGON1989-10-31
K771948 — GLUCAGON RIA MODULE1978-01-20

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

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