510(k) K820320
K820320 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "MODEL 3030 ATOMIC ABSORPTION SPECTRO-". The FDA issued a decision of Substantially Equivalent on March 1, 1982. The device falls under product code JXR (Atomic Absorption Spectrophotometer, General Use), a Class I device regulated under 21 CFR 862.2850. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1982
- Date Received
- February 5, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Atomic Absorption Spectrophotometer, General Use
- Device Class
- Class I
- Regulation Number
- 862.2850
- Review Panel
- TX
- Submission Type