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510(k) K863071

PHOSPHOLIPIDS-E by J. D. Assoc. — Product Code CEQ

K863071 is an FDA 510(k) premarket notification submitted by J. D. Assoc. for the device "PHOSPHOLIPIDS-E". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code CEQ (Molybdenum Blue Method, Phospholipids), a Class I device regulated under 21 CFR 862.1575. J. D. Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Molybdenum Blue Method, Phospholipids
Device Class
Class I
Regulation Number
862.1575
Review Panel
CH
Submission Type

Other clearances by J. D. Assoc.

  • K863103 — PEG 6,000 (January 13, 1987)
  • K863054 — AST S.C.E. (GOT) (January 13, 1987)
  • K863069 — MAGNESIOMETER (December 31, 1986)
  • K863079 — CREATINKINETIC (December 12, 1986)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863102 — GLUCOMETER-E (November 24, 1986)
  • K863109 — FERROFAST (November 24, 1986)

FDA data resources