510(k) K896237
K896237 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS READY ALT REAGENT". The FDA issued a decision of Substantially Equivalent on February 16, 1990. The device falls under product code CKD (Hydrazone Colorimetry, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1990
- Date Received
- October 31, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hydrazone Colorimetry, Alt/Sgpt
- Device Class
- Class I
- Regulation Number
- 862.1030
- Review Panel
- CH
- Submission Type