MDKClass I

Dna-Probe, Reagents, Streptococcal

21 CFR 866.3740 / Microbiology

MDK is the FDA product code for Dna-Probe, Reagents, Streptococcal, a class I device type, regulated under 21 CFR 866.3740. As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 1998-09-24, and 2 recalls.

Classification record

Product code: MDK
Device name: Dna-Probe, Reagents, Streptococcal
Regulation: 21 CFR 866.3740
Device class: Class I
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 2

Clearances, product code MDK

By decision year

4 clearances under product code MDK with a decision year between 1990 and 1998, 1990 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code MDK by decision year
Year	Clearances
1990	1
1992	1
1994	1
1998	1

Applicants with the most clearances

Product code MDK

Applicants holding the most 510(k) clearances under product code MDK
Applicant	Clearances
Hologic, Inc.	3
Chugai Pharmaceuticals Co., Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MDK.