ACCESS FREE T3 ASSAY— 510(k) K960913
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K960913 for ACCESS FREE T3 ASSAY, Substantially Equivalent on 1996-03-29. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code CDP
- Device class
- Class 2
- Regulation
- 21 CFR 862.1710
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code CDP
view allMore clearances from Bio-Rad Laboratories, Inc.
view allAdverse events under product code CDP
product code CDP- Malfunction
- 647
- Total
- 647
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K960913
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960913.
Data sourced from openFDA. This site is unofficial and independent of the FDA.