510(k) K780713
K780713 is an FDA 510(k) premarket notification submitted by Royal Scientific, Inc. for the device "CULTURE SWAB". The FDA issued a decision of Substantially Equivalent on May 12, 1978. The device falls under product code JRW (Antisera, Fluorescent, B. Parapertussis), a Class I device regulated under 21 CFR 866.3065.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1978
- Date Received
- April 27, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, B. Parapertussis
- Device Class
- Class I
- Regulation Number
- 866.3065
- Review Panel
- MI
- Submission Type