510(k) K760908
K760908 is an FDA 510(k) premarket notification submitted by Ackerman Nuclear, Inc. for the device "MINIATURE ASCENDING PAPER CHROMATO-". The FDA issued a decision of Substantially Equivalent on Nov 19, 1976. The device falls under product code DPA (Apparatus, General Use, Thin Layer Chromatography), a Class I device regulated under 21 CFR 862.2270.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 19, 1976
- Date Received
- Oct 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Apparatus, General Use, Thin Layer Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2270
- Review Panel
- TX
- Submission Type
- 510(k) Exempt