MKZClass I
Dna Probe, Nucleic Acid Amplification, Chlamydia
21 CFR 866.3120 / Microbiology
MKZ is the FDA product code for Dna Probe, Nucleic Acid Amplification, Chlamydia, a class I device type, regulated under 21 CFR 866.3120. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- MKZ
- Device name
- Dna Probe, Nucleic Acid Amplification, Chlamydia
- Regulation
- 21 CFR 866.3120
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 19
- Ingested recalls
- 3
Clearances, product code MKZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 2 |
| 2012 | 1 |
| 2014 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code MKZ| Applicant | Clearances |
|---|---|
| Hologic, Inc. | 6 |
| Roche Molecular Systems Inc | 5 |
| Becton Dickinson & Co | 4 |
| Roche Diagnostics GmbH | 2 |
| Abbott Medical | 1 |
| Abbott Molecular, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.