510(k) K780389
K780389 is an FDA 510(k) premarket notification submitted by Worthington Biochemical Corp. for the device "HDL REAGENT SET FOR LIPOPROTEINS". The FDA issued a decision of Substantially Equivalent on April 19, 1978. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Worthington Biochemical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1978
- Date Received
- March 10, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Esterase--Oxidase, Cholesterol
- Device Class
- Class I
- Regulation Number
- 862.1175
- Review Panel
- CH
- Submission Type