510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843330Substantially Equivalent

Systemate Phosphorus 67217

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

K843330 is the FDA 510(k) clearance record for SYSTEMATE PHOSPHORUS 67217, a class I device, cleared for Em Diagnostic Systems, Inc. on under FDA product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus). FDA records list 288 510(k) clearances for Em Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K843330.

Clearance record

Decision date
Received
(18 days to decision)
Product code
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Regulation
21 CFR 862.1580
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Em Diagnostic Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CEO

Trailing 12 months

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

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