Medical Device Manufacturer · CA , Burnaby, British Columbia

Response Biomedical Corp. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2001

Recent clearances: MODIFICATION TO: RAMP INFLUENZA A/B ASSAY, RAMP RSV ASSAY, RAMP NT-PROBNP ASSAY

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Response Biomedical Corp. Chemistry ✕

4 devices

1-4 of 4

Cleared Jul 21, 2008

RAMP NT-PROBNP ASSAY

Chemistry · 591d

Cleared May 17, 2004

RAMP TROPONIN I ASSAY

Chemistry · 168d

Cleared May 17, 2004

RAMP CK-MB ASSAY

Chemistry · 168d

Cleared Dec 18, 2001

RAMP MYOGLOBIN ASSAY

Chemistry · 172d