FDA product code MDK: Dna-Probe, Reagents, Streptococcal
MDK is the FDA product code for dna-probe, reagents, streptococcal. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under MDK, from 2 different applicants. The average 510(k) review took 246 days (median 195). FDA has posted 2 recalls for MDK devices.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe, Reagents, Streptococcal |
| Device class | Class I |
| Regulation | 21 CFR 866.3740 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MDK clearance
Top MDK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 3 | 1994-03-11 |
| Chugai Pharmaceuticals Co., Ltd. | 1 | 1998-09-24 |
Most recent MDK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974572 | Chugai Pharmaceuticals Co., Ltd. | GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 | 1998-09-24 | 293 |
| K924715 | Gen-Probe, Inc. | GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST | 1994-03-11 | 536 |
| K915852 | Gen-Probe, Inc. | ACCUPACE GROUP A STREPTOCOCCUS ID TEST | 1992-04-02 | 97 |
| K904268 | Gen-Probe, Inc. | ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. | 1990-11-13 | 56 |
Recalls for MDK devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-12-30.
Frequently asked questions
What is FDA product code MDK?
MDK is the FDA product code for dna-probe, reagents, streptococcal. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel.
What device class is MDK?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MDK?
Across 4 cleared submissions the average was 246 days from receipt to decision (median 195).
Which companies have the most MDK clearances?
Gen-Probe, Inc. (3); Chugai Pharmaceuticals Co., Ltd. (1).
Have MDK devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2008-12-30.
Next steps
- Run an FDA pathway report with predicate devices for product code MDK
- Run a recall and safety report across every MDK manufacturer
- Watch product code MDK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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