510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033747Substantially Equivalent

Ramp Ck-Mb Assay

Response Biomedical Corp., Burnaby, British Columbia, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033747 is the FDA 510(k) clearance record for RAMP CK-MB ASSAY, a class II device, cleared for Response Biomedical Corp. on under FDA product code JHX (Fluorometric Method, Cpk Or Isoenzymes). FDA records list 7 510(k) clearances for Response Biomedical Corp., from to . As of , FDA records show no recalls naming K033747.

Clearance record

Decision date
Received
(168 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
Response Biomedical Corp. 8081 Lougheed Hwy., Burnaby, British Columbia, CA
510(k) summary
Summary PDF
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