Autostat II Anti-Gpc Elisa, Hy.Tec Anti-Gpc Elisa

FDA 510(k) K991942 · Cogent Diagnotics , Ltd.

Substantially Equivalent

510(k) numberK991942

Submission

Device name
Autostat II Anti-Gpc Elisa, Hy.Tec Anti-Gpc Elisa
Applicant
Cogent Diagnotics , Ltd.
Midlothian, Scotland, GB
Received
June 9, 1999
Decision date
August 24, 1999
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)DeviceApplicantDecision
K010558Quanta Lite Gpa (Gastric Parietal Cell Antibody) ElisaMLE · Traditional Inova Diagnostics, Inc.04/03/2001SE
K951206Varelisa Parietal Cell AntibodiesMLE · Traditional Elias U.S.A., Inc.04/17/1995SE

More from Elias U.S.A., Inc.

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K002215Autostat II Anti-Myeloperoxidase (Mpo) ElisaMOB · Traditional 09/28/2000SE
K993557Autostat II Rheumatoid Factor Iga ElisaDHR · Traditional 03/03/2000SE
K994338Autostat II Rheumatoid Factor Igm ElisaDHR · Traditional 02/03/2000SE
K993085Autostat II Anti-Cardiolipin Screen ElisaMID · Traditional 02/01/2000SE
K993304Autostat II Rheumatoid Factor Igg ElisaDHR · Traditional 12/06/1999SE
K992449Autostat II Anti-Cardiolipin Igm ElisaMID · Traditional 11/24/1999SE
K993087Autostat II Anti-Gliadin Igg ElisaMST · Traditional 11/12/1999SE
K993086Autostat II Anti-Gliadin Iga ElisaMST · Traditional 11/12/1999SE

Questions and answers

When was Autostat II Anti-Gpc Elisa, Hy.Tec Anti-Gpc Elisa cleared by the FDA?

Autostat II Anti-Gpc Elisa, Hy.Tec Anti-Gpc Elisa (K991942) received a 510(k) decision of Substantially Equivalent on August 24, 1999, 76 days after the submission was received.

What is the product code of K991942?

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.