510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884085Substantially Equivalent

Tandem Icon QSR Ckmb Immunoenzymetric Assay

Hybritech, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884085 is the FDA 510(k) clearance record for TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY, a class II device, cleared for Hybritech, Inc. on under FDA product code JHY (Colorimetric Method, Cpk Or Isoenzymes). FDA records list 63 510(k) clearances for Hybritech, Inc., from to . As of , FDA records show no recalls naming K884085.

Clearance record

Decision date
Received
(66 days to decision)
Product code
JHY Colorimetric Method, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hybritech, Inc. 11095 Torreyana Rd., San Diego CA
Third party review
No

Clearances, product code JHY

Trailing 12 months

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

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