510(k) K021428
K021428 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM". The FDA issued a decision of Substantially Equivalent on July 5, 2002. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Bayer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 5, 2002
- Date Received
- May 3, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Method, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type