510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823761Substantially Equivalent

Erythrocyte & Stand Sediment. Rate Tube

Cordis US Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823761 is the FDA 510(k) clearance record for ERYTHROCYTE & STAND SEDIMENT. RATE TUBE, a class I device, cleared for Cordis Corp. on under FDA product code JPH (Test, Erythrocyte Sedimentation Rate). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K823761.

Clearance record

Decision date
Received
(38 days to decision)
Product code
JPH Test, Erythrocyte Sedimentation Rate
Regulation
21 CFR 864.6700
Device class
Class I
Review panel
Hematology
Applicant
Cordis Corp. 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