El-Ana Profiles: Anti-Ribosomal Protein P
FDA 510(k) K024151 · Theratest Laboratories, Inc.
510(k) numberK024151
Submission
- Device name
- El-Ana Profiles: Anti-Ribosomal Protein P
- Applicant
- Theratest Laboratories, Inc.
Lombard, IL, US - Received
- December 6, 2002
- Decision date
- February 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MQA – Anti-Ribosomal P Antibodies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code MQA
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Questions and answers
When was El-Ana Profiles: Anti-Ribosomal Protein P cleared by the FDA?
El-Ana Profiles: Anti-Ribosomal Protein P (K024151) received a 510(k) decision of Substantially Equivalent on February 6, 2003, 62 days after the submission was received.
What is the product code of K024151?
The FDA product code is MQA – Anti-Ribosomal P Antibodies, a Class II (moderate risk) device regulated under 21 CFR 866.5100.