Quanta Lite Gpa (Gastric Parietal Cell Antibody) Elisa

Q: What is the product code of K010558?

The FDA product code is MLE – Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5110.

FDA 510(k) K010558 · Inova Diagnostics, Inc.

Substantially Equivalent

510(k) numberK010558

Submission

Device name: Quanta Lite Gpa (Gastric Parietal Cell Antibody) Elisa
Applicant: Inova Diagnostics, Inc.
San Diego, CA, US
Received: February 26, 2001
Decision date: April 3, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: MLE – Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5110
Specialty: Immunology

Other 510(k)s with product code MLE

510(k)	Device	Applicant	Decision
K991942	Autostat II Anti-Gpc Elisa, Hy.Tec Anti-Gpc ElisaMLE · Traditional	Cogent Diagnotics , Ltd.	08/24/1999SE
K951206	Varelisa Parietal Cell AntibodiesMLE · Traditional	Elias U.S.A., Inc.	04/17/1995SE

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Questions and answers

When was Quanta Lite Gpa (Gastric Parietal Cell Antibody) Elisa cleared by the FDA?

Quanta Lite Gpa (Gastric Parietal Cell Antibody) Elisa (K010558) received a 510(k) decision of Substantially Equivalent on April 3, 2001, 36 days after the submission was received.

What is the product code of K010558?

The FDA product code is MLE – Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5110.