510(k) K842709
K842709 is an FDA 510(k) premarket notification submitted by Immucell Corp. for the device "IMMUSTAPH LATEX AGGLUTINATION KIT". The FDA issued a decision of Substantially Equivalent on Aug 3, 1984. The device falls under product code LHJ (Staphylococcus Aureus Protein A Insoluble), a Class I device regulated under 21 CFR 866.3700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 1984
- Date Received
- Jul 12, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staphylococcus Aureus Protein A Insoluble
- Device Class
- Class I
- Regulation Number
- 866.3700
- Review Panel
- MI
- Submission Type
- 510(k) Exempt