Product code LJK— Microbiology
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
- Classification name
- Antisera, If, Toxoplasma Gondii
- Device class
- Class 2
- Regulation
- 21 CFR 866.3780
- Advisory panel
- Microbiology
- Total cleared
- 6
- First cleared
- Most recent
Market context for product code LJK
FDA has cleared devices under product code LJK between 1982 and 1997, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1997
- 1991
- 1987
- 1986
- 1983
- 1982
Top applicants under product code LJK
Recent clearances under product code LJK
Data sourced from openFDA. This site is unofficial and independent of the FDA.