510(k) K812434
K812434 is an FDA 510(k) premarket notification submitted by Diagnostica, Inc. for the device "DIAGNOSTIC KITS & KIT COMPONENTS". The FDA issued a decision of Substantially Equivalent on Sep 23, 1981. The device falls under product code LHT (Staphylococcus Aureus Somatic Antigens), a Class I device regulated under 21 CFR 866.3700. Diagnostica, Inc. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 23, 1981
- Date Received
- Aug 25, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Staphylococcus Aureus Somatic Antigens
- Device Class
- Class I
- Regulation Number
- 866.3700
- Review Panel
- MI
- Submission Type
- 510(k) Exempt