510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894288Substantially Equivalent

Phosphorus Test Item Number 65416

Em Diagnostic Systems, Inc., Gibbstown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894288 is the FDA 510(k) clearance record for PHOSPHORUS TEST ITEM NUMBER 65416, a class I device, cleared for Em Diagnostic Systems, Inc. on under FDA product code CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase). FDA records list 288 510(k) clearances for Em Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K894288.

Clearance record

Decision date
Received
(69 days to decision)
Product code
CED 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Regulation
21 CFR 862.1520
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Em Diagnostic Systems, Inc. 480 Democrat Rd., Gibbstown NJ
Third party review
No

Clearances, product code CED

Trailing 12 months

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

FDA records show no clearances under product code CED in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CED, 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