Chromagar Candida
FDA 510(k) K960075 · Hardy Diagnostics
510(k) numberK960075
Submission
- Device name
- Chromagar Candida
- Applicant
- Hardy Diagnostics
Santa Maria, CA, US - Received
- January 11, 1996
- Decision date
- August 2, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JXC – Kit, Screening, Yeast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JXC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K913426 | Albicans SureJXC · Traditional | Jrga Diagnostics | 04/22/1992SE |
| K884720 | Germ Tube SolutionJXC · Traditional | Remel Co. | 06/02/1989SE |
| K891476 | C. Albicans ScreenJXC · Traditional | Carr-Scarborough Microbiologicals, Inc. | 04/12/1989SE |
| K882371 | Soc Slide Culture SystemJXC · Traditional | The Cancer Center AT Wadley Institutes | 07/18/1988SE |
| K832406 | Quantum II Yeast Ident. SystemJXC · Traditional | Abbott Laboratories | 09/26/1983SE |
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Questions and answers
When was Chromagar Candida cleared by the FDA?
Chromagar Candida (K960075) received a 510(k) decision of Substantially Equivalent on August 2, 1996, 204 days after the submission was received.
What is the product code of K960075?
The FDA product code is JXC – Kit, Screening, Yeast, a Class I (low risk) device regulated under 21 CFR 866.2660.