Hcc-Mycobacteria Stain Kit
FDA 510(k) K833131 · Dr. C.V. Jacob
510(k) numberK833131
Submission
- Device name
- Hcc-Mycobacteria Stain Kit
- Applicant
- Dr. C.V. Jacob
Mchenry, IL, US - Received
- September 13, 1983
- Decision date
- October 27, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023677 | Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv)LIB · Traditional | Osmetech | 01/29/2003SE |
| K920416 | Supplementary Reagents for Enzygnost/TmbLIB · Traditional | Behring Diagnostics, Inc. | 04/08/1992SE |
| K912558 | Gull ElisawareLIB · Traditional | Gull Laboratories, Inc. | 09/16/1991SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 07/07/1987SE |
| K871559 | Cell LifterLIB · Traditional | Corning Costar Corp. | 05/15/1987SE |
| K864249 | Normal Saline SterileLIB · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 10/03/1986SE |
| K862112 | Microscope SlidesLIB · Traditional | Abco Dealers, Inc. | 06/13/1986SE |
| K854604 | Auto MashLIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854603 | Multi Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
Questions and answers
When was Hcc-Mycobacteria Stain Kit cleared by the FDA?
Hcc-Mycobacteria Stain Kit (K833131) received a 510(k) decision of Substantially Equivalent on October 27, 1983, 44 days after the submission was received.
What is the product code of K833131?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.