510(k) K760197
K760197 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "ACCUVETTE II". The FDA issued a decision of Substantially Equivalent on July 19, 1976. The device falls under product code JRI (Cuvette, Thermostated), a Class I device regulated under 21 CFR 862.2050. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1976
- Date Received
- July 6, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuvette, Thermostated
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type