JTR — Kit, Quality Control For Culture Media Class I

FDA Device Classification

FDA product code JTR covers "Kit, Quality Control For Culture Media", a Class I medical device regulated under 21 CFR 866.2480. Submissions are reviewed by the Microbiology panel. At least 12 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JTR
Device Class
Class I
Regulation Number
866.2480
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K871121pro-labPROTECT T.M.April 14, 1987
K862914trend scientificFEKAL CHECK PARASITOLOGY CONTROL SLIDESeptember 16, 1986
K861022micro-bio-logicsKWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSApril 4, 1986
K855198micro-bio-logicsINDI KWIK (TM) CO/TWO KITJanuary 14, 1986
K842579biological and environmental control laboratoriesB.E.C. GROWTH CHEK MICROBIAL SUSPENSIONSJuly 27, 1984
K842129micro-bio-logicsLYFO-DISK MICROORGANISMSJuly 3, 1984
K831653austin biological laboratoriesLYOPHILIZED MICROORGANISMSJuly 28, 1983
K830133lab abilityQ-CHECK CULTI-LOOPSFebruary 9, 1983
K822954universal micro reference laboratoryMICROTECH BACTERIAL CONTROLSNovember 16, 1982
K821660american scientific productsBIO-CHECK GRAM STAIN CONTROLJune 25, 1982
K820064american type culture collectionSUSCEPTROLJanuary 28, 1982
K812698remelGC DISKOctober 6, 1981