510(k) K883185
K883185 is an FDA 510(k) premarket notification submitted by Norfolk Scientific, Inc. for the device "SAFECRIT PLASTIC MICROHEMATOCRIT TUBES". The FDA issued a decision of Substantially Equivalent on August 18, 1988. The device falls under product code GHY (Hematocrit, Tube, Rack, Sealer, Holder), a Class II device regulated under 21 CFR 864.6400. Norfolk Scientific, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1988
- Date Received
- July 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hematocrit, Tube, Rack, Sealer, Holder
- Device Class
- Class II
- Regulation Number
- 864.6400
- Review Panel
- HE
- Submission Type