Immunwell Sjogren`S Syndrome B (la) Antibody Test
FDA 510(k) K911850 · General Biometrics, Inc.
510(k) numberK911850
Submission
- Device name
- Immunwell Sjogren`S Syndrome B (la) Antibody Test
- Applicant
- General Biometrics, Inc.
San Diego, CA, US - Received
- April 26, 1991
- Decision date
- May 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKO – Anti-Rnp Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K920400 | Immunowell Cardiolipin Antibody (Igg) TestMID · Traditional | 08/20/1992SE |
| K911627 | Immunodot Borrelia (Lyme) TestLSR · Traditional | 04/08/1992SE |
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| K911590 | Immunowell Borrelia (Lyme)TestLSR · Traditional | 12/20/1991SE |
| K914801 | Immunowell Dsdna Antibody TestDHC · Traditional | 12/09/1991SE |
| K911851 | Immunowell SM Antibody TestLKP · Traditional | 05/07/1991SE |
| K911849 | Immunowell Sjogrens Syndrome a (Ro)Antibody TestLKO · Traditional | 05/07/1991SE |
| K911848 | Immunowell Rnp/Sm Antibody TestLKP · Traditional | 05/07/1991SE |
Questions and answers
When was Immunwell Sjogren`S Syndrome B (la) Antibody Test cleared by the FDA?
Immunwell Sjogren`S Syndrome B (la) Antibody Test (K911850) received a 510(k) decision of Substantially Equivalent on May 7, 1991, 11 days after the submission was received.
What is the product code of K911850?
The FDA product code is LKO – Anti-Rnp Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.