Varelisa Parietal Cell Antibodies

FDA 510(k) K951206 · Elias U.S.A., Inc.

Substantially Equivalent

510(k) numberK951206

Submission

Device name
Varelisa Parietal Cell Antibodies
Applicant
Elias U.S.A., Inc.
Osceola, WI, US
Received
March 17, 1995
Decision date
April 17, 1995
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
K991942Autostat II Anti-Gpc Elisa, Hy.Tec Anti-Gpc ElisaMLE · Traditional Cogent Diagnotics , Ltd.08/24/1999SE

More from Cogent Diagnotics , Ltd.

510(k)DeviceDecision
K964385Elias ANA-HEP-2LJM · Traditional 03/06/1997SE
K963291Varelisa Ana (4) ProfileLJM · Traditional 09/30/1996SE
K953873Varelisa Helicobacter Pylori AntibodiesLYR · Traditional 08/30/1996SE
K953587Varelisa Mpo-AncaMOB · Traditional 01/26/1996SE
K953586Varelisa PR3-ANCAMOB · Traditional 01/26/1996SE
K951187Varelisa Cardiolipin Abs ScreenMID · Traditional 10/02/1995SE
K951207Varelisa Histone AntibodiesLJM · Traditional 04/17/1995SE
K951205Varelisa Ana ProfileLJM · Traditional 04/17/1995SE
K951186Varelisa ANA-4 ScreenLJM · Traditional 04/17/1995SE
K944334Varelisa Combined DNA Antibodies EiaLRM · Traditional 04/17/1995SE

Questions and answers

When was Varelisa Parietal Cell Antibodies cleared by the FDA?

Varelisa Parietal Cell Antibodies (K951206) received a 510(k) decision of Substantially Equivalent on April 17, 1995, 31 days after the submission was received.

What is the product code of K951206?

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.