510(k) K851275
K851275 is an FDA 510(k) premarket notification submitted by Gibco Laboratories Life Technologies, Inc. for the device "GIBCO MYCOTECT 189-5670". The FDA issued a decision of Substantially Equivalent on June 21, 1985. The device falls under product code KIW (Kit, Mycoplasma Detection), a Class I device regulated under 21 CFR 864.2360. Gibco Laboratories Life Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1985
- Date Received
- April 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Mycoplasma Detection
- Device Class
- Class I
- Regulation Number
- 864.2360
- Review Panel
- PA
- Submission Type