510(k) K922801
K922801 is an FDA 510(k) premarket notification submitted by Light Diagnostics for the device "RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY". The FDA issued a decision of Substantially Equivalent on January 6, 1993. The device falls under product code GNY (Antisera, Fluorescent, Adenovirus 1-33), a Class I device regulated under 21 CFR 866.3020. Light Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1993
- Date Received
- June 10, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, Adenovirus 1-33
- Device Class
- Class I
- Regulation Number
- 866.3020
- Review Panel
- MI
- Submission Type