510(k) K780888
K780888 is an FDA 510(k) premarket notification submitted by Gilford Instrument Laboratories, Inc. for the device "THERMO SET ELECTRONIC TEM. CONTROLLER". The FDA issued a decision of Substantially Equivalent on June 28, 1978. The device falls under product code JRI (Cuvette, Thermostated), a Class I device regulated under 21 CFR 862.2050. Gilford Instrument Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1978
- Date Received
- May 26, 1978
- 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