MDK — Dna-Probe, Reagents, Streptococcal Class I
FDA product code MDK covers "Dna-Probe, Reagents, Streptococcal", a Class I medical device regulated under 21 CFR 866.3740. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MDK
- Device Class
- Class I
- Regulation Number
- 866.3740
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974572 | chugai pharmaceuticals co | GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 | September 24, 1998 |
| K924715 | gen-probe | GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST | March 11, 1994 |
| K915852 | gen-probe | ACCUPACE GROUP A STREPTOCOCCUS ID TEST | April 2, 1992 |
| K904268 | gen-probe | ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. | November 13, 1990 |