510(k) K991261
K991261 is an FDA 510(k) premarket notification submitted by Research Instruments , Ltd. for the device "ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET". The FDA issued a decision of Substantially Equivalent on August 5, 1999. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Research Instruments , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1999
- Date Received
- April 13, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microtools, Assisted Reproduction (Pipettes)
- Device Class
- Class II
- Regulation Number
- 884.6130
- Review Panel
- OB
- Submission Type