510(k) K822734
K822734 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "EBV IGM TEST". The FDA issued a decision of Substantially Equivalent on December 9, 1982. The device falls under product code JRY (Antiserum, Fluorescent, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1982
- Date Received
- September 9, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Fluorescent, Epstein-Barr Virus
- Device Class
- Class I
- Regulation Number
- 866.3235
- Review Panel
- MI
- Submission Type