510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K870987Substantially Equivalent

Ciba Corning Magic(r) Lite Ckmb Immunoassay

Ciba Corning Diagnostics Corp., East Walpole MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870987 is the FDA 510(k) clearance record for CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY, a class II device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code JHX (Fluorometric Method, Cpk Or Isoenzymes). FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K870987.

Clearance record

Decision date
Received
(76 days to decision)
Product code
JHX Fluorometric Method, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ciba Corning Diagnostics Corp. 333 Coney St., East Walpole MA
Third party review
No

Clearances, product code JHX

Trailing 12 months

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

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