510(k) K812759
K812759 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "NML CK-MB RIA". The FDA issued a decision of Substantially Equivalent on Oct 19, 1981. The device falls under product code JHX (Fluorometric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Nuclear Medical Laboratories, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 19, 1981
- Date Received
- Oct 1, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Fluorometric Method, Cpk Or Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1215
- Review Panel
- CH
- Submission Type
- 510(k)