510(k) K801876
K801876 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "STREP B POLYVALENT FLUORO-KIT". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code GTX (Antisera, Fluorescent, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 1980
- Date Received
- August 5, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, All Groups, Streptococcus Spp.
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type