510(k) K884004
K884004 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "RUBEOLA TEST". The FDA issued a decision of Substantially Equivalent on December 5, 1988. The device falls under product code GRE (Antiserum, Fluorescent, Rubeola), a Class I device regulated under 21 CFR 866.3520. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1988
- Date Received
- September 21, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Fluorescent, Rubeola
- Device Class
- Class I
- Regulation Number
- 866.3520
- Review Panel
- MI
- Submission Type