510(k) K842310
K842310 is an FDA 510(k) premarket notification submitted by Hml Inc/Biotechnology Transfer for the device "HEMATOLOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on September 6, 1984. The device falls under product code JKL (Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry), a Class I device regulated under 21 CFR 862.1060. Hml Inc/Biotechnology Transfer has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 1984
- Date Received
- June 12, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
- Device Class
- Class I
- Regulation Number
- 862.1060
- Review Panel
- CH
- Submission Type