510(k) K862542
K862542 is an FDA 510(k) premarket notification submitted by Supelco, Inc. for the device "CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY". The FDA issued a decision of Substantially Equivalent on August 4, 1986. The device falls under product code DII (Columns, Glc), a Class I device regulated under 21 CFR 862.2250. Supelco, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1986
- Date Received
- July 3, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Columns, Glc
- Device Class
- Class I
- Regulation Number
- 862.2250
- Review Panel
- TX
- Submission Type