510(k) K792557
K792557 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "SPECTROPHATOMETER MODELS 2280 & 2380AA". The FDA issued a decision of Substantially Equivalent on January 16, 1980. 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
- January 16, 1980
- Date Received
- December 10, 1979
- 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