510(k) K980525
K980525 is an FDA 510(k) premarket notification submitted by Marukin Shoyu Co., Ltd. for the device "UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD". The FDA issued a decision of Substantially Equivalent on April 15, 1998. The device falls under product code KWX (Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids), a Class II device regulated under 21 CFR 862.1187.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 1998
- Date Received
- February 11, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
- Device Class
- Class II
- Regulation Number
- 862.1187
- Review Panel
- CH
- Submission Type