510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840500Substantially Equivalent

Sediplast

Precision Technology, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840500 is the FDA 510(k) clearance record for SEDIPLAST, a class I device, cleared for Precision Technology, Inc. on under FDA product code JPH (Test, Erythrocyte Sedimentation Rate). FDA records list 3 510(k) clearances for Precision Technology, Inc., from to . As of , FDA records show no recalls naming K840500.

Clearance record

Decision date
Received
(15 days to decision)
Product code
JPH Test, Erythrocyte Sedimentation Rate
Regulation
21 CFR 864.6700
Device class
Class I
Review panel
Hematology
Applicant
Precision Technology, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JPH

Trailing 12 months

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

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