510(k) K870769
K870769 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "AUSTIN NONFERMENTER KIT". The FDA issued a decision of Substantially Equivalent on Apr 3, 1987. The device falls under product code JSW (Kit, Identification, Glucose Nonfermenter), a Class I device regulated under 21 CFR 866.2660. Austin Biological Laboratories has 44 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 3, 1987
- Date Received
- Feb 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Kit, Identification, Glucose Nonfermenter
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt