Immuno Dot Borrelia Dot Blot G Test
FDA 510(k) K953682 · Genbio
510(k) numberK953682
Submission
- Device name
- Immuno Dot Borrelia Dot Blot G Test
- Applicant
- Genbio
San Diego, CA, US - Received
- August 7, 1995
- Decision date
- May 3, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was Immuno Dot Borrelia Dot Blot G Test cleared by the FDA?
Immuno Dot Borrelia Dot Blot G Test (K953682) received a 510(k) decision of Substantially Equivalent on May 3, 1996, 270 days after the submission was received.
What is the product code of K953682?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.