510(k) K020489
K020489 is an FDA 510(k) premarket notification submitted by Tosoh Medics, Inc. for the device "G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE". The FDA issued a decision of Substantially Equivalent on May 14, 2002. The device falls under product code JPD (Hemoglobin A2 Quantitation), a Class II device regulated under 21 CFR 864.7400. Tosoh Medics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2002
- Date Received
- February 13, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobin A2 Quantitation
- Device Class
- Class II
- Regulation Number
- 864.7400
- Review Panel
- HE
- Submission Type