Gen-Probe Beta-Lactamase Test Kit
FDA 510(k) K870422 · Gen-Probe, Inc.
510(k) numberK870422
Submission
- Device name
- Gen-Probe Beta-Lactamase Test Kit
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- February 3, 1987
- Decision date
- April 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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| K955826 | Gibson Id-M. Cat.JTO · Traditional | Gibson Laboratories, Inc. | 02/29/1996SE |
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Questions and answers
When was Gen-Probe Beta-Lactamase Test Kit cleared by the FDA?
Gen-Probe Beta-Lactamase Test Kit (K870422) received a 510(k) decision of Substantially Equivalent on April 21, 1987, 77 days after the submission was received.
What is the product code of K870422?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.