TITAN GEL ISO DOT CPK PROCEDURE— 510(k) K842755
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K842755 for TITAN GEL ISO DOT CPK PROCEDURE, Substantially Equivalent on 1984-09-28. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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