Gene-Trak Campylobacter Assay
FDA 510(k) K863270 · Integrated Genetics
510(k) numberK863270
Submission
- Device name
- Gene-Trak Campylobacter Assay
- Applicant
- Integrated Genetics
Framingham, MA, US - Received
- August 25, 1986
- Decision date
- August 31, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQO – Dna-Reagents, Campylobacter Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
Other 510(k)s with product code LQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894712 | Accuprobe Campylobacter Culture ConfirmationLQO · Traditional | Gen-Probe, Inc. | 11/14/1989SE |
| K873670 | Snap Campylobactor Diagnostic KitLQO · Traditional | Molecular Biosystems, Inc. | 06/08/1988SE |
| K875101 | Virogen CMV Antibody TestLQO · Traditional | Wampole Laboratories | 03/01/1988SE |
Questions and answers
When was Gene-Trak Campylobacter Assay cleared by the FDA?
Gene-Trak Campylobacter Assay (K863270) received a 510(k) decision of Substantially Equivalent on August 31, 1987, 371 days after the submission was received.
What is the product code of K863270?
The FDA product code is LQO – Dna-Reagents, Campylobacter Spp., a Class I (low risk) device regulated under 21 CFR 866.3110.