510(k) K883205
K883205 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics, Inc. for the device "ALTLTS ALANINE AMINO TRANSFERASE ALT". The FDA issued a decision of Substantially Equivalent on September 9, 1988. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Electro-Nucleonics, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1988
- Date Received
- July 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Device Class
- Class I
- Regulation Number
- 862.1030
- Review Panel
- CH
- Submission Type