HY-TEC AUTOMATED EIA SYSTEM— 510(k) K941278
Substantially EquivalentHycor Biomedical, Inc.
FDA 510(k) clearance K941278 for HY-TEC AUTOMATED EIA SYSTEM, Substantially Equivalent on 1995-03-13. Applicant: Hycor Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Hycor Biomedical, Inc.
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Garden Grove, CA, US
Recent devices under product code DHB
view allMore clearances from Hycor Biomedical, Inc.
view allRecalls naming K941278
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 K941278.
Data sourced from openFDA. This site is unofficial and independent of the FDA.