Lyme Igm Microassay
510(k) K911330
Lyme Igm Microassay is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K911330 on 10 Jun 1991, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911330 | Date10 Jun 1991 | StatusActive |
Official records
- FDA 510(k) database K911330
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LSR
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3830
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LSR (Reagent, Borrelia Serological Reagent).
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- LYME DISEASE IFA (IGM) by Hillcrest Biologicals
- PLATELIA LYME IGG ASSAY by Bio-Rad
- FASTTECH SYSTEM 1 by 3M Diagnostic Systems, Inc.
- VIDAS LYME SCREEN II by Biomerieux Vitek, Inc.
- BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM by ZEUS SCIENTIFIC, INC.