Borrelia Burgdorferi Igg/Igm Elisa Test System
FDA 510(k) K965131 · Wampole Laboratories
510(k) numberK965131
Submission
- Device name
- Borrelia Burgdorferi Igg/Igm Elisa Test System
- Applicant
- Wampole Laboratories
Cranbury, NJ, US - Received
- December 23, 1996
- Decision date
- March 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LSR – Reagent, Borrelia Serological Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
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More from Gold Standard Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K965129 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | 03/26/1997SE |
| K911444 | Rubella Virus Immunological Test SystemLFX · Traditional | 08/30/1991SE |
| K882896 | One-Step HCGDHA · Traditional | 10/31/1988SE |
| K883004 | Mono-Plus(Tm)KTN · Traditional | 08/04/1988SE |
| K875101 | Virogen CMV Antibody TestLQO · Traditional | 03/01/1988SE |
| K875161 | Mat (TM) Microalbumin TestDCF · Traditional | 02/17/1988SE |
| K791309 | Ucg-LyphotestJHJ · Traditional | 07/30/1979SE |
| K790986 | RF ControlsDMR · Traditional | 06/28/1979SE |
| K781794 | Beta-TecJHI · Traditional | 12/29/1978SE |
| K760336 | Biocept-GJHI · Traditional | 11/12/1976SE |
Questions and answers
When was Borrelia Burgdorferi Igg/Igm Elisa Test System cleared by the FDA?
Borrelia Burgdorferi Igg/Igm Elisa Test System (K965131) received a 510(k) decision of Substantially Equivalent on March 26, 1997, 93 days after the submission was received.
What is the product code of K965131?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.