510(k) K131580
K131580 is an FDA 510(k) premarket notification submitted by Tosoh Bioscience, Inc. for the device "AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8". The FDA issued a decision of Substantially Equivalent on January 23, 2014. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Tosoh Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2014
- Date Received
- May 31, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobin A1c Test System
- Device Class
- Class II
- Regulation Number
- 862.1373
- Review Panel
- CH
- Submission Type
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.