510(k) K894389
K894389 is an FDA 510(k) premarket notification submitted by Catachem, Inc. for the device "CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS". The FDA issued a decision of Substantially Equivalent on October 12, 1989. The device falls under product code GGX (Pipette, Sahli), a Class I device regulated under 21 CFR 864.6160. Catachem, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1989
- Date Received
- July 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pipette, Sahli
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type