510(k) K831268
K831268 is an FDA 510(k) premarket notification submitted by Pasco Laboratories, Inc. for the device "TILL-U-TEST G.C. GONOCOCUS SLIDE". The FDA issued a decision of Substantially Equivalent on May 13, 1983. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Pasco Laboratories, Inc. has 65 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1983
- Date Received
- Apr 18, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, For Isolation Of Pathogenic Neisseria
- Device Class
- Class II
- Regulation Number
- 866.2410
- Review Panel
- MI
- Submission Type
- 510(k)