Home / 510(k) Clearances / K900218

510(k) K900218

J&S HDL CHOLESTEROL PRECIPITATING REAGENT by J.S. Medical Assoc. — Product Code LBL

K900218 is an FDA 510(k) premarket notification submitted by J.S. Medical Assoc. for the device "J&S HDL CHOLESTEROL PRECIPITATING REAGENT". The FDA issued a decision of Substantially Equivalent on June 18, 1990. The device falls under product code LBL (Tube, Tympanostomy, Porous Polyethylene), a Class II device regulated under 21 CFR 874.3880. J.S. Medical Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1990
Date Received
January 17, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tympanostomy, Porous Polyethylene
Device Class
Class II
Regulation Number
874.3880
Review Panel
EN
Submission Type

Other clearances by J.S. Medical Assoc.

  • K932752 — VISI-SPOT (November 5, 1993)
  • K932688 — EYE SPOT IM TEST (September 8, 1993)
  • K932180 — EYE SPOT CRP TEST (August 23, 1993)
  • K932551 — ACCUTEX IM LATEX TEST (August 9, 1993)
  • K926112 — ACCUTEX BETA-HCG TEST (July 28, 1993)
  • K924332 — ACCUTEX CRP LATEX TEST (December 7, 1992)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K924036 — ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST (December 1, 1992)
  • K924248 — ACCUTEX SLE LATEX TEST (November 2, 1992)
  • K924037 — ACCUTEX IM RBC TEST (November 2, 1992)

FDA data resources