Product code LKH— Microbiology
CELLMATICS SHLAMYDIA DETECTION SYSTEM
- Classification name
- Antisera, Immunoperoxidase, Chlamydia Spp.
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- Advisory panel
- Microbiology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code LKH
FDA has cleared devices under product code LKH between 1982 and 1991, filed by 7 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.
Clearances per year
- 1991
- 1989
- 1985
- 1984
- 1983
- 1982
Top applicants under product code LKH
Recent clearances under product code LKH
- K910644 — IPAZYME (TM) CHLAMYDIA IGG-IGA
- K901975 — IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)
- K882674 — IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
- K893669 — CELLMATICS SHLAMYDIA DETECTION SYSTEM
- K852869 — SELECTICULT-CHLAMYDIA
- K842151 — CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT
- K830688 — COMBION SKIN TEST
- K820390 — HISTOSET IMMUNOPEROXIDASE TISSURE KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.