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510(k) K863065

HDL CHOLESTEROL-E by J. D. Assoc.

K863065 is an FDA 510(k) premarket notification submitted by J. D. Assoc. for the device "HDL CHOLESTEROL-E". The FDA issued a decision of Substantially Equivalent on September 25, 1986. J. D. Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by J. D. Assoc.

  • K863054 — AST S.C.E. (GOT) (January 13, 1987)
  • K863103 — PEG 6,000 (January 13, 1987)
  • K863069 — MAGNESIOMETER (December 31, 1986)
  • K863079 — CREATINKINETIC (December 12, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863056 — BILIRUBIN TOTAL (November 24, 1986)
  • K863102 — GLUCOMETER-E (November 24, 1986)

FDA data resources