510(k) K780757
K780757 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "KRYORACK/4". The FDA issued a decision of Substantially Equivalent on June 6, 1978. The device falls under product code JRR (Regulator, Temperature), a Class I device regulated under 21 CFR 862.2050. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 1978
- Date Received
- May 8, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Regulator, Temperature
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type