510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863071Substantially Equivalent

Phospholipids-E

J. D. Assoc., Montclair NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863071 is the FDA 510(k) clearance record for PHOSPHOLIPIDS-E, a class I device, cleared for J. D. Assoc. on under FDA product code CEQ (Molybdenum Blue Method, Phospholipids). FDA records list 34 510(k) clearances for J. D. Assoc., from to . As of , FDA records show no recalls naming K863071.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CEQ Molybdenum Blue Method, Phospholipids
Regulation
21 CFR 862.1575
Device class
Class I
Review panel
Clinical Chemistry
Applicant
J. D. Assoc. 163 Montclair Ave., Montclair NJ
Third party review
No

Clearances, product code CEQ

Trailing 12 months

FDA records hold no clearances under product code CEQ in the trailing twelve months.

FDA records show no clearances under product code CEQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CEQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260