510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883503Substantially Equivalent

Coulter Viscometer II

Coulter Electronics, Inc., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883503 is the FDA 510(k) clearance record for COULTER VISCOMETER II, a class I device, cleared for Coulter Electronics, Inc. on under FDA product code JJL (Plasma Viscometer For Clinical Use). FDA records list 101 510(k) clearances for Coulter Electronics, Inc., from to . As of , FDA records show no recalls naming K883503.

Clearance record

Decision date
Received
(33 days to decision)
Product code
JJL Plasma Viscometer For Clinical Use
Regulation
21 CFR 862.2920
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Coulter Electronics, Inc. 745 W. 83rd St., Hialeah FL
Third party review
No

Clearances, product code JJL

Trailing 12 months

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

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