510(k) K832933
K832933 is an FDA 510(k) premarket notification submitted by Jerome Instrument Corp. for the device "GOLD FILM MERCURY ANALYZER #511". The FDA issued a decision of Substantially Equivalent on November 25, 1983. The device falls under product code DPH (Mercury, Atomic Absorption), a Class I device regulated under 21 CFR 862.3600.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1983
- Date Received
- August 30, 1983
- 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