Anemia Control

FDA 510(k) K812635 · Environmental Chemical Specialties

Substantially Equivalent

510(k) numberK812635

Submission

Device name
Anemia Control
Applicant
Environmental Chemical Specialties
Mchenry, IL, US
Received
September 15, 1981
Decision date
October 2, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJY – Multi-Analyte Controls, All Kinds (Assayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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More from Aalto Scientific, Ltd.

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K811809Anti-Arrhythmic Control Levels I & IIDIF · Traditional 07/10/1981SE
K803089Gamma-Glutamyl Transpeptidase (GGT)JPZ · Traditional 01/02/1981SE
K792377Carcinoembryonic Antigen (Cea) ControlDHX · Traditional 09/26/1980SE
K801854Spinal Fluid Control(Human)JJX · Traditional 09/16/1980SE
K801061Total Protein TestCEK · Traditional 07/21/1980SE
K792376Quantitative Control Urine II (Human)JJW · Traditional 12/06/1979SE
K792375Elevated Lipid ControlJJY · Traditional 12/06/1979SE
K792374Quantitative Control Urine I (Human)JJW · Traditional 12/06/1979SE

Questions and answers

When was Anemia Control cleared by the FDA?

Anemia Control (K812635) received a 510(k) decision of Substantially Equivalent on October 2, 1981, 17 days after the submission was received.

What is the product code of K812635?

The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.