510(k) K820647
K820647 is an FDA 510(k) premarket notification submitted by Gamma Biologicals, Inc. for the device "GAMMA FETAL BLEED SCREENING TEST". The FDA issued a decision of Substantially Equivalent on May 12, 1982. The device falls under product code LIM (Test, Screening, For D Positive Fetal Rbc'S), a Class II device regulated under 21 CFR 864.7455. Gamma Biologicals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1982
- Date Received
- March 9, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Screening, For D Positive Fetal Rbc'S
- Device Class
- Class II
- Regulation Number
- 864.7455
- Review Panel
- HE
- Submission Type