Product code MDK— Microbiology

FDA has cleared 4 devices under product code MDK between 1990 and 1998, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19981 clearance
• 19941 clearance
• 19921 clearance
• 19901 clearance

• Gen-Probe, Inc.3 clearances
• Chugai Pharmaceuticals Co., Ltd.1 clearance

• K974572 — GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820Chugai Pharmaceuticals Co., Ltd.·1998-09-24
• K924715 — GEN-PROBE DIRECT GROUP A STREPTOCOCUS TESTGen-Probe, Inc.·1994-03-11
• K915852 — ACCUPACE GROUP A STREPTOCOCCUS ID TESTGen-Probe, Inc.·1992-04-02
• K904268 — ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.Gen-Probe, Inc.·1990-11-13