Quanta Lite Ribosome P Elisa

FDA 510(k) K981237 · Inova Diagnostics, Inc.

Substantially Equivalent

510(k) numberK981237

Submission

Device name
Quanta Lite Ribosome P Elisa
Applicant
Inova Diagnostics, Inc.
San Diego, CA, US
Received
April 3, 1998
Decision date
June 5, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MQA – Anti-Ribosomal P Antibodies
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Specialty
Immunology

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K950169Ribosomal P Eia Test SystemMQA · Traditional Hogan & Hartson05/23/1996SE

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Questions and answers

When was Quanta Lite Ribosome P Elisa cleared by the FDA?

Quanta Lite Ribosome P Elisa (K981237) received a 510(k) decision of Substantially Equivalent on June 5, 1998, 63 days after the submission was received.

What is the product code of K981237?

The FDA product code is MQA – Anti-Ribosomal P Antibodies, a Class II (moderate risk) device regulated under 21 CFR 866.5100.