510(k) K840261
K840261 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "CAL-CHEX, A HEMATOLOGY CALIBRATOR". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1984
- Date Received
- January 5, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator For Hemoglobin And Hematocrit Measurement
- Device Class
- Class II
- Regulation Number
- 864.8165
- Review Panel
- HE
- Submission Type