510(k) K761226
K761226 is an FDA 510(k) premarket notification submitted by Supelco, Inc. for the device "GP3%SP-2100DOHON100/120 MESH SUPELCOPORT". The FDA issued a decision of Substantially Equivalent on January 14, 1977. The device falls under product code JSQ (Chromatography For Bacterial Identification), 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
- January 14, 1977
- Date Received
- December 9, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chromatography For Bacterial Identification
- Device Class
- Class I
- Regulation Number
- 862.2250
- Review Panel
- TX
- Submission Type