510(k) K780237
K780237 is an FDA 510(k) premarket notification submitted by Owens-Illinois, Inc. for the device "DISPOSABLE CONTROLLED DROP PASTEUR PIPET". The FDA issued a decision of Substantially Equivalent on March 9, 1978. The device falls under product code GJG (Pipette, Quantitative, Hematology), a Class I device regulated under 21 CFR 864.6160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1978
- Date Received
- February 13, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pipette, Quantitative, Hematology
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type