510(k) K781010
K781010 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code DPH (Mercury, Atomic Absorption), a Class I device regulated under 21 CFR 862.3600. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1978
- Date Received
- June 16, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mercury, Atomic Absorption
- Device Class
- Class I
- Regulation Number
- 862.3600
- Review Panel
- TX
- Submission Type