CPK - ISOENZYMES— 510(k) K760028
Substantially EquivalentHarleco
FDA 510(k) clearance K760028 for CPK - ISOENZYMES, Substantially Equivalent on 1976-09-15. Applicant: Harleco. Device class: 2.
Clearance details
- Applicant
- Harleco
- Product code
- Code JHT
- 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
Recent devices under product code JHT
view all- K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
- K991299 — MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
- K930359 — CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
- K904721 — DSL CK-MB (DSL #3200)
- K904866 — COULTER CK-MB ISOENZYME REAGENT
More clearances from Harleco
view allData sourced from openFDA. This site is unofficial and independent of the FDA.