510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851942Substantially Equivalent

Coulter Double Check, Unassayed Serum Chemistry

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

K851942 is the FDA 510(k) clearance record for COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY, a class I device, cleared for Coulter Electronics, Inc. on under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). FDA records list 101 510(k) clearances for Coulter Electronics, Inc., from to . As of , FDA records show no recalls naming K851942.

Clearance record

Decision date
Received
(28 days to decision)
Product code
JJY Multi-Analyte Controls, All Kinds (Assayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Coulter Electronics, Inc. 440 W. 20 St., Hialeah FL
Third party review
No

Clearances, product code JJY

Trailing 12 months

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

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