510(k) K841026
K841026 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "MANUAL BLOOD CELL COUNTING DEVICE". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code GKM (Hand-Tally, Differential), a Class I device regulated under 21 CFR 864.6160. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1984
- Date Received
- March 12, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hand-Tally, Differential
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type