510(k) K874188
K874188 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA". The FDA issued a decision of Substantially Equivalent on January 19, 1988. The device falls under product code GKM (Hand-Tally, Differential), a Class I device regulated under 21 CFR 864.6160. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 1988
- Date Received
- October 14, 1987
- 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