510(k) K761241
K761241 is an FDA 510(k) premarket notification submitted by Gibco Laboratories Life Technologies, Inc. for the device "PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE". The FDA issued a decision of Substantially Equivalent on December 30, 1976. The device falls under product code JTX (Transport Systems, Anaerobic), a Class I device regulated under 21 CFR 866.2900. Gibco Laboratories Life Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1976
- Date Received
- December 13, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transport Systems, Anaerobic
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type