510(k) K812013
K812013 is an FDA 510(k) premarket notification submitted by Springwood Microbiologicals for the device "FLUORESCENT ANTIBODY CONJUGATE FOR GP.A". The FDA issued a decision of Substantially Equivalent on July 28, 1981. The device falls under product code GTX (Antisera, Fluorescent, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Springwood Microbiologicals has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1981
- Date Received
- July 17, 1981
- 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